what does a clinical research project manager do

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What Does a Clinical Project Manger Do? Roles & Responsibilities

What does a Clinical Project Manager Do?

Clinical Project Managers (CPM) play a crucial role in advancing the progress of a clinical trial. The significance of CPMs lies in their ability to navigate complex clinical trials, ensuring precision, compliance, and efficiency.

As stewards of the entire research lifecycle, from planning to execution, Clinical Project Managers wield strategic thinking, leadership insight, and a deep understanding of regulatory landscapes.

In a world where the pursuit of groundbreaking therapies intensifies, the demand for skilled managers is reaching new heights, with organizations recognizing their pivotal role in trial success.

This blog explores the pivotal responsibilities of clinical project managers and sheds light on why their expertise is becoming increasingly coveted, underscoring the crucial role they play in shaping the future of healthcare.

Table of Contents:

What is a Clinical Project Manager?

What does a clinical project manager do, skills required to become a clinical project manager.

Essential Certifications or Degrees Required to become a Clinical Project Manager

How to Become a Clinical Project Manager?

Salary and job outlook for a clinical project manager.

A Clinical Project Manager (CPM) is an experienced expert in clinical research and healthcare management who is responsible for managing and coordinating the different aspects of clinical trials.

This multifaceted role encompasses strategic planning, execution, and monitoring of clinical research projects to ensure they adhere to regulatory standards, timelines, and budgets.

Clinical Project Manager acts as a connecting point between research teams, sponsors, regulatory authorities, and other stakeholders, facilitating effective communication and collaboration.

Clinical Project Manager responsibilities include protocol development, risk management , team leadership, and navigating the complexities of regulatory compliance. By leveraging their expertise in project management, scientific understanding, and regulatory knowledge, they contribute significantly to successful clinical trials, ultimately advancing medical knowledge and bringing novel treatments to needy patients.

A Clinical Project Manager (CPM) is a pivotal figure in clinical trials, overseeing the intricate processes that lead to the successful execution of healthcare research. Their role encompasses many responsibilities, blending scientific expertise with project management skills to ensure the seamless progression of clinical trials.

Other key roles and responsibilities of a Clinical Project Manager:

Strategic Planning: Develop comprehensive plans for the initiation, execution, and completion of clinical trials, aligning them with project goals and timelines
Protocol Development: Contribute to the creation and refinement of study protocols, outlining the methodology, objectives, and criteria for participant selection
Site Selection: Identify and evaluate suitable clinical trial sites, considering factors such as patient demographics, facilities, and regulatory compliance
Regulatory Compliance: Navigate and ensure adherence to the complex web of regulatory requirements, obtaining necessary approvals and permissions for the clinical trial
Budget Oversight: Manage the financial aspects of the clinical trial, ensuring adherence to the allocated budget and making informed decisions to optimize resource utilization
Data Integrity: Oversee data collection and management processes, emphasizing the importance of data accuracy, completeness, and compliance with regulatory standards
Problem Resolution: Address challenges and obstacles that may arise during the trial, making decisions that safeguard patient safety and ensure the integrity of the study
Quality Assurance: Maintain a focus on the overall quality of the clinical trial, implementing measures to uphold ethical standards, patient welfare, and the reliability of research outcomes

Becoming a successful clinical project manager requires a diverse set of skills that combines scientific knowledge, project management proficiency, and effective communication. Below are some of the key skills that a clinical project manager is required to excel in the role:

1. Project Management Skills

Planning and Organization: Ability to develop and execute comprehensive project plans, ensuring all aspects of the clinical trial are well-coordinated
Time Management: Efficiently allocate resources, manage timelines, and prioritize tasks to meet project milestones
Risk Management: Identify potential risks and proactively implement strategies to mitigate them, ensuring smooth project progression

2. Scientific Understanding Skills

Clinical Research Knowledge: Familiarity with the principles and processes of clinical research, including study design, protocols, and ethical considerations
Medical Terminology: Ability to understand and interpret medical and scientific terminology crucial for effective communication with research teams and stakeholders

3. Communication Skills

Interpersonal Communication: Build strong professional relationships with diverse stakeholders , including research teams, sponsors, regulatory authorities, and site personnel
Presentation Skills: Effectively convey complex information clearly and concisely, verbally and in written form

4. Leadership and Team Management Skills

Team Building: Foster collaboration and cohesion within cross-functional teams, inspiring motivation and commitment to project goals
Decision-Making: Make informed decisions promptly, especially in high-pressure situations, to address challenges and keep the project on track

5. Regulatory Knowledge and Skills

Regulatory Compliance: Stay updated on and ensure adherence to relevant regulations and guidelines governing clinical trials in different regions
Ethical Considerations: Understand and navigate the ethical considerations in clinical research, prioritizing patient safety and welfare

6. Problem-Solving Skills

Critical Thinking: Analyze complex situations, identify root causes of issues, and develop effective solutions to keep the project moving forward

7. Financial Acumen

Budget Management: Proficiency in managing project budgets, optimizing resource allocation, and ensuring financial accountability throughout the trial

8. Adaptability Skills

Flexibility: Navigate unforeseen challenges and changes in project scope with adaptability, adjusting strategies and plans as needed
Learning Agility: Stay abreast of advancements in clinical research, project management methodologies, and regulatory requirements

Essential Certifications or Degrees Required to Become a Clinical Project Manager

Becoming a Clinical Project Manager requires a combination of education, relevant degrees, and professional certifications. The specific requirements may vary based on the employer, industry sector, and the clinical trials complexity.

Here are some essential certifications and degrees that can enhance the qualifications of individuals aspiring to become Clinical Project Managers:

1. Educational Background

Bachelor’s Degree: A bachelor’s degree in an appropriate field such as life sciences, healthcare, nursing, pharmacy, or a related discipline is frequently the minimum educational requirement
Advanced Degrees: While not always mandatory, having a master’s degree (e.g., Master of Public Health, Master of Science in Clinical Research) or a Ph.D. can be advantageous, especially for more senior or specialized roles

2. Project Management Professional (PMP) Certification

The PMP certification is offered by the Project Management Institute (PMI), is widely recognized, and demonstrates proficiency in project management principles. It is valuable for Clinical Project Managers as they oversee complex clinical trials.

Achieve global recognition with the PMP certification from Invensis Learning. Benefit from expert trainers, flexible learning options, and success guarantees to propel your career to new heights. Enroll now to access exclusive discounts and become a certified leader in project management.

3. Certified Clinical Research Professional (CCRP) Certification

The Certified Clinical Research Professional (CCRP) certification is a professional designation offered by the Society of Clinical Research Associates (SoCRA). It is a worldwide recognized credential that demonstrates an individual’s skills and understanding of the principles and practices of clinical research.

4. Project Management Fundamentals (PMF) Certification

The Project Management Fundamentals (PMF) Certification is an entry-level credential offered by the Association for Project Management (APM) that validates an individual’s understanding of the fundamental principles and practices of project management. It is designed for those new to the field or wanting to formalize their project management knowledge.

5. Certified Clinical Project Manager (CCPM) Certification

The Certified Clinical Project Manager (CCPM) certification is a professional designation offered by various organizations that demonstrates an individual’s expertise in managing clinical trials and research projects. It validates their ability to effectively plan, execute, monitor, and evaluate clinical research studies, ensuring adherence to regulatory and ethical guidelines.

How to Become a Clinical Project Manager

Becoming a Clinical Project Manager involves a strategic combination of education, experience, and professional development. Here’s a step-by-step guide on how to embark on a career as a Clinical Project Manager:

1. Get a Bachelor’s and a Master’s Degree

Embark on your journey by earning a bachelor’s degree in a relevant field, such as life sciences or healthcare. This foundational step equips you with essential knowledge for a career in clinical research.

To enhance your qualifications further, pursue a master’s degree, opting for specialized programs like a Master’s in Public Health (MPH) or a Master’s in Clinical Research.

2. Opt for an Entry-level Clinical Job

Kickstart your career with an entry-level position in clinical research, such as a Clinical Research Assistant or Coordinator. These roles expose you to the day-to-day operations of clinical trials, providing valuable insights into research protocols, data management, and regulatory compliance.

3. Gain Clinical Research Experience

Actively seek hands-on experience in clinical research, engaging in tasks like patient recruitment and study coordination. Develop a strong understanding of Good Clinical Practice (GCP) guidelines and ethical considerations. This practical experience lays the groundwork for a well-rounded skill set and prepares you for more advanced roles.

4. Build a Strong Resume

Create an effective resume that highlights your educational background, relevant coursework, and practical experience. Emphasize key skills such as attention to detail, data management, and knowledge of regulatory standards. Include certifications, like GCP, to underscore your commitment to maintaining high-quality standards in clinical research.

5. Find a Position as a Clinical Project Manager

Progress in your career by applying for roles with increasing responsibilities, focusing on project management within clinical trials. Leverage your educational background, practical experience, and certifications to showcase readiness for a Clinical Project Manager role. Highlight your ability to lead teams, manage timelines, and strictly adhere to regulatory standards.

Before switching any career, individuals should know two main things: one is salary growth and the other one is job opportunities. The salary and job outlook for a Clinical Project Manager (CPM) can vary based on factors such as experience, education, location, and the specific industry within healthcare or clinical research. It’s essential to note that salary trends and job outlook may evolve over time.

Salary of a Clinical Project Manager

The salary prospects for a clinical project manager are generally quite positive. They play a crucial role in the healthcare industry, overseeing the planning, execution, and monitoring of clinical trials and research projects.

Their expertise in project management, clinical research methodology, and regulatory compliance ensures the successful completion of these studies, leading to the development of new drugs, treatments, and medical devices.

Experience is a significant factor in determining salary. The salary ranges for clinical project managers are as follows:

Clinical project managers have the potential to experience significant salary growth throughout their careers. With increasing experience, specialized skills, and advanced certifications, clinical project managers can advance into senior-level positions with higher earning potential.

Additionally, the demand for clinical project managers is expected to grow faster than average in the coming years, further contributing to positive salary prospects.

Job Outlook of a Clinical Project Manager

The job outlook for clinical project managers is exceptionally promising, driven by the increasing demand for clinical trials, the growing complexity of research projects, and the expanding healthcare needs of an aging population.

As per the US Bureau of Labor Statistics (BLS) , employment of medical and health services managers, which includes clinical project managers, will expand by 32% from 2020 to 2030, much faster than the average for all professions. This growth is related to the aging population and the increasing demand for healthcare services.

Here are some specific factors that contribute to the positive job outlook for clinical project managers:

Increasing demand for clinical trials
Growing complexity of clinical trials
The aging population and rising healthcare needs
Expansion of medical group practices

Clinical project managers can pursue diverse career paths and advance into senior-level positions with increasing responsibilities and higher compensation.

Some potential career trajectories include:

Clinical Research Associate (CRA)
Clinical Research Coordinator
Clinical Research Manager
Director of Clinical Research
Clinical Research Program Manager
Clinical Research Portfolio Manager
Clinical Project Manager Specialist
Clinical Project Manager Lead
Global Clinical Project Manager
Senior Clinical Project Manager
Executive Clinical Project Manager

A clinical project manager plays a pivotal role in the healthcare industry, ensuring the successful execution of clinical trials and research projects. Their expertise in project management, clinical research methodology, and regulatory compliance is crucial for bringing new drugs, devices, and therapies to patients, improving healthcare outcomes, and advancing medical knowledge.

If you are passionate about healthcare, have strong organizational skills, and possess a keen eye for detail, a career as a clinical project manager could be a rewarding and fulfilling path. With the right education, experience, and certifications, you can significantly impact the future of healthcare by overseeing the development of life-saving treatments and technologies.

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Clinical research project management: back to basics.

Clinical trials require care and precision regarding planning, coordination, and collaboration. The stakes are high, with participants’ health and well-being and significant investments of both time and money on the line. That’s why clinical research project managers are necessary – to ensure coordinated and collaborative efforts between numerous departments, teams, and vendors that adhere to the study protocol as well as regulatory and ethical standards. In this article, we will take an in-depth look at the basics of clinical research project management.

What is project management in clinical research?

Clinical trials involve several complex, dynamic parts with different boundaries/areas of responsibility, and personnel with specific skill sets and qualifications. As a consequence, successful clinical trials require organizers who are adept at project management.

Clinical trials can be thought of as large-scale, complex projects with multiple milestones and parallel workstreams, including:

Study and protocol design
Study startup
Site activation
Recruitment
Documentation (promotional material, informed consent forms, case report forms, protocol documents, surveys, etc.)
IRB and IEC approval
Site management
Investigational product distribution and management of study materials
Laboratories (analyses, lab tests, imaging, etc.)
Reporting and regulatory affairs

Why is project management in clinical research important?

Clinical research involves multiple stakeholders. Project management can essentially be thought of as monitoring progress and keeping everyone involved on the same page. Project management is critical for the success of a clinical trial; it helps the different teams stay on schedule, adhere to protocol, and communicate amongst one another, as well as meet the trial objectives/targets, maintain quality standards, stay within budget, and follow regulatory requirements.

The following are three major reasons why project management in clinical research is important:

Timeline management

Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1] Project management techniques can allow investigators to plan ahead if it looks like a deadline is not going to be met, so they can reallocate resources and priorities to accelerate the process, or otherwise notify teams responsible for tasks that would be affected by the resultant delay and adjust the timelines.

Streamline and facilitate communications

It is important for the various stakeholders involved in a clinical trial to be on the same page. Keeping all of these actors updated and facilitating communication amongst them is another task of the project management team. Lack of communication in clinical trials can have negative consequences on the quality of research. [2] An efficient project manager or management team can streamline communication and collaboration between multiple teams and departments, further increasing the transparency of the individual but interdependent operations.

Quality control (QC)

Quality control is another important aspect of clinical research project management. Quality standards are often stringent, but this is designed to protect the safety of participants and the general population. Clinical trials that fail to adhere to or meet quality standards will not be considered to have provided sufficient evidence on the effectiveness and/or safety of an investigational drug. Researchers and investigators tend to be under a lot of pressure as trials are often on tight budgets and timelines, but it is important that quality not be sacrificed in order to meet other objectives.

Project management helps sponsors/investigators manage all objectives and sub-tasks in a clinical trial while still prioritizing adherence to quality and regulatory standards. Part of the task of the project management team may even be to define internal quality standards for specific tasks, objectives, and/or teams.

What does a clinical research project manager do?

A clinical research project manager coordinates with other departments, teams, and personnel involved in the clinical trial to ensure the organized completion of clearly defined tasks. They also manage external vendors such as central laboratories or technology providers. Project managers will monitor the progress of all tasks and objectives to keep the study on track according to its protocol, including timeline and budget, and also communicate with stakeholders such as the sponsor to keep them up to date.

What is the clinical research project manager responsible for?

The responsibilities of a clinical research project manager depend on the specifics of the trial and its complexity, but they generally include the following:

Planning : This includes general planning of the trial, including the internal organization between departments/teams, how tasks should be executed in order to comply with regulations, how many and which sites to involve, whether external tools/solutions need to be contracted, etc.
Budgeting : Making sure that the study’s resources are allocated appropriately to the different teams/tasks, within the overall study budget, also providing room for unexpected costs or delays.
Vendor identification/selection : Negotiation with vendors, technology providers, and suppliers.
Scheduling : Scheduling the objectives/sub-tasks of the clinical trial and monitoring activities to make sure they are completed on time.
Liaising : Acting as a central point of contact for members of the project team and sponsors.
Task delegation : Assigning tasks to team members and updating them about their responsibilities, as well as deadlines and expectations.

What are the key topics included in a clinical research project plan?

The project manager may organize all of the above-mentioned tasks and responsibilities into a document or repository referred to as a clinical research project plan. This plan would formally outline standard protocols for aspects of the clinical research project management, such as:

Timeline : The timeline should clearly outline specific tasks for each team/department, including their expected initiation and completion dates, and the project manager will ensure tasks and teams are on track. Clinical trials often get delayed, so it is useful to have protocols in place regarding how to deal with potential delays. [3]
Budget : Often related to unexpected delays, it is not uncommon for projects to end up over budget. The project plan should clearly define budgets, both for teams and for individual tasks, and should outline how deviations from budgets should be dealt with.
Stakeholder management : The project management plan should outline the content and dates of formal reports for keeping stakeholders updated about the trial’s progress.
Documentation : The project plan should outline how documentation should be collected, organized, stored, and verified in order to ensure compliance with laws as well as ethical and clinical standards as established by the WHO and ICH guidelines for Clinical Good Practice.
Site management : Although site monitoring is usually a separate responsibility in clinical trials, the project plan may include instructions and guidelines for individual study sites regarding adherence to protocol, tasks, and timelines. In addition, sites should have clear guidelines on who to contact in the case of any problems, questions, or adverse events that may arise during the trial.
Data management : The project plan should specify protocol for the collection, secure storage, management, validation, and cleaning of subject information and trial data, in accordance with quality standards and applicable regulations. Proper data management ties in closely with quality assurance, and sound results require healthy data.

Tips for successful clinical research project planning and management

Here are 4 specific tips and ideas for maximizing the efficacy of project management functions in clinical research.

1. Plan with flexibility

Delays can be hard to avoid, especially in the recruitment stage, and they are costly to sponsors. Nonetheless, proper consideration of these potential delays in the timeline (i.e., allowing for some degree of flexibility) can make the difference between the delays simply setting the trial back a few weeks, or ending in the entire trial being canceled.

While delays aren’t ideal, proper planning can allow the sponsors to absorb these delays without them leading to completely missed deadlines and/or cancellation of the trial; in the end, cancellation likely represents a much more significant waste of resources than delays. The same logic can be applied to flexibility in budgeting, as delays may imply additional costs; if these are less unexpected, they can be better absorbed within the trial budget without setting it entirely off track.

2. Identify possible risks and establish mitigation strategies

Perform a thorough analysis of the protocol and utilize specialist knowledge in the fields of medicine and clinical research management to identify and create a list of risks that could arise throughout the clinical trial. Planning ahead of time will allow sponsors to respond rapidly to these risk factors and mitigate them, without having to perform lengthy analyses and coming up with mitigation strategies when it may be too late.

Some potential risks to consider include recruitment delays or low accrual, adverse events, patient dropouts, protocol breaches, problems with study drug supply or distribution, technical failures (of software systems, medical equipment, etc.), and data integrity issues, to name a few. Start with the risks that pose the greatest threat to the integrity of the study, i.e., those which would result in it being canceled, stopped, or rendering the results unusable.

3. Use project management tools

Constantly reviewing all aspects of the clinical trial is a daunting task, so the use of specialized and customizable software solutions can be helpful. There are many such solutions available, from general project management tools to dedicated clinical trial management systems ( CTMS ). These tools can be of significant help in managing, organizing, and overviewing all of the aspects of project management discussed previously, acting as a sort of central dashboard as well as a “safeguard” for the project management plan and tasks.

4. Leverage data automation tools and functions

Similarly to the previous point, data management is another aspect of clinical trials (and clinical trial project management) that can benefit greatly from the assistance of technological tools. Lots of data management functions, including organization, cleanup, and validation, can be streamlined or even completely automated through data processing tools, which are sometimes integrated directly into CTMS or other clinical trial monitoring solutions. The benefits of healthy data include enhanced regulatory compliance and faster progression to data analysis and results once the study data has been collected. Data can also be improved at the source through the use of electronic reporting/collection/recording methods such as:

Electronic patient-reported outcomes ( ePRO )
Electronic trial master files ( eTMF )
Electronic clinical outcome assessments ( eCOA )
Electronic case report forms ( eCRF )

Conclusions

Clinical research project management is a vital function for keeping the numerous separate yet highly interconnected parts involved in a clinical trial operating in coordination and on track with protocol, budget, timelines, and regulations. There are numerous strategies and tools that can facilitate clinical trial project management tasks and help improve clinical trial quality and speed while still ensuring patient safety and regulatory compliance.

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What Does a Clinical Project Manager do?

Clinical Project Managers (CPM) play a vital role in the healthcare and pharmaceutical industries, overseeing the successful execution of clinical trials from inception to completion. This position bridges the gap between the scientific and administrative aspects of clinical research, ensuring that projects are carried out efficiently, within budget, and in compliance with regulatory standards.

CPMs are responsible for designing project plans, setting timelines, and assembling teams of professionals, including clinicians, scientists, and statisticians, to ensure that clinical trials are conducted according to the project’s objectives.

What are the Main Responsibilities of a CPM?

The exact responsibilities will vary from role to role, but may include:

Maintaining required records of study activity, including case report forms, drug dispensation records, or regulatory forms.
Monitoring study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
Overseeing subject enrolment to ensure that informed consent is properly obtained and documented.
Assessing eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
Recording adverse event and side effect data and conferring with investigators regarding the reporting of events to oversight agencies.
Preparing for or participating in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Identifying protocol problems, informing investigators of problems, and assisting in problem resolution efforts such as protocol revisions.
Preparing study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
Tracking enrolment status of subjects and document dropout information such as dropout causes and subject contact efforts.
Reviewing proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
Evaluating and interpreting collected study data.
Participating in the preparation and management of research budgets and monetary disbursements.
Participating in the development of study protocols including guidelines for administration or data collection procedures.
Instructing research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
Communicating with laboratories or investigators regarding laboratory findings.
Reviewing scientific literature, participating in continuing educational activities, or attending conferences and seminars to maintain current knowledge of clinical supplies affairs and issues.
Ordering drugs or devices necessary for study completion.
Providing regular updates to internal teams as well as stakeholders, including trial sponsors.
Determining how many participants are needed for the trial and setting criteria for involvement.
Maintaining safety standards and protecting trial participants.

What are the Main Benefits of Working as a CPM?

The role of CPM is an appealing career path for individuals interested in the intersection of healthcare, research, and project management. One of the foremost benefits is the opportunity to play a critical role in advancing medical science and improving patient outcomes. Through the management of clinical trials, CPMs contribute directly to the development of new drugs, treatments, and medical technologies. This can provide a deep sense of purpose and fulfilment, knowing that one’s work has a tangible impact on people’s lives and well-being around the world.

Additionally, the role of CPM is characterised by dynamic and diverse responsibilities, ensuring that no two days are the same. This variety keeps the job engaging and intellectually stimulating, as CPMs are constantly learning and adapting to new challenges. The position also offers excellent opportunities for professional growth and career advancement within the pharmaceutical, biotechnology, and healthcare industries.

Furthermore, the global nature of clinical trials provides possibilities for international collaboration and even travel, adding an exciting dimension to the job.

What Experience, Skills and Qualifications Are Needed to Become a CPM?

Some of the key experience, skills, and qualifications typically required to become a CPM include:

Bachelor’s degree in life sciences, nursing, pharmacy, medical sciences, or related field
Advanced degree in a healthcare or science-related field (highly valued)
Certifications such as the Certified Clinical Project Manager (CCPM) or Project Management Professional (PMP)
Experience in clinical research and conducting clinical trials
Management experience
Strong project management skills, including strategic planning, resource allocation, and execution
Excellent communication and interpersonal skills
Analytical and problem-solving skills
Knowledge of regulatory requirements and guidelines such as FDA regulations, ICH guidelines, and Good Clinical Practice (GCP)
Attention to detail
IT proficiency, including familiarity with clinical trial management systems (CTMS), electronic data capture (EDC), and data management tools

How is the Role of CPM Evolving?

The role of CPM is evolving, driven by advancements in technology, the increasing complexity of clinical trials, and a greater focus on personalised medicine. As the global health landscape shifts and clinical trials grow in complexity, CPMs are required to manage not only the logistics and team dynamics but also integrate the latest innovations such as digital health technologies, wearable devices, and real-time data analytics. This incorporation of technology enhances trial efficiency and data accuracy, demanding that CPMs are proficient not only in project management but also in tech-savviness.

Additionally, the push towards more patient-centric trials, adaptive trial designs, and the proliferation of multinational studies require CPMs to handle more diverse regulatory environments and cultural considerations. This involves staying abreast of international regulations and being adept at managing cross-border teams and trials.

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Article updated April 2024.

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What does a clinical trial project manager do?

what does a clinical research project manager do

Well-structured clinical trials have always been a cornerstone of the life sciences industry. Yet with projects becoming increasingly complex, competition intensifying and public/governmental pressure to improve standards, this area is set to become more challenging in the coming years.

In fact, international health organisations are establishing programs that deal with drug safety and their rollout across the globe. For example, the World Health Organisation (WHO) has rolled out the “Medication Without Harm” initiative in order to promote better processes and standards for medications - including the use of more extensive and thorough clinical trials.

Clinical Trial Project Managers play a major role in supporting these ambitious targets and pursuing a project manager career can be both challenging and rewarding. In this article, we explore the key role that Clinical Trial Project Managers play in clinical trials and the steps you can take to start or progress in this area.

Clinical Trial Project Manager: Responsibilities

Clinical Trail Project Managers can have a broad range of responsibilities, each differing slightly depending on the business they work for and the projects they work on. However, there are some commonalities across the board for those that find themselves in these roles.

For example, at the core of their responsibilities, all Clinical Trial Project Managers are responsible for leading clinical studies. This also typically includes supporting the planning, set up and coordination processes of clinical trials. Depending on the business/sector you work in, this may include leading trials on medical devices, medicines or nutritional products.

Other responsibilities may include:

Developing and managing budgets
Ensuring trials are conducted in line with industry guidelines and legislation
Identifying and mitigating potential trial risks
Support patient eligibility checks
Resolving protocol deviation issues
Acting as the main point of contact for sponsors and project teams
Assisting in the preparation of Clinical Study Reports (CSRs)
Reporting on clinical trial progress
Negotiation with suppliers
Supporting the creation of clinical trial proposals
Support the general running of clinical trials and help overcome any potential issues

Why are Clinical Trial Project Managers important?

Clinical Trial Project Managers are key in ensuring the smooth running and successful completion of these trials within the CRO space and they’re playing an increasingly pivotal role as the market develops.

Clinical trials undertook a key role in overcoming the covid-19 pandemic. The rapid approach to getting vaccines approved has drastically changed how these types of trials are approached . A call for faster, but more comprehensive trials is a big challenge that Clinical Trail Project Managers can help overcome.

There are three main reasons why Clinical Trial Project Managers are so important within clinical trials:

They ensure that best practices and legislation are followed, improving the strength of the trial and its results
They facilitate the smooth running of trials, ensuring the project team can focus on their area of expertise
They support clear communication between trial sponsors and project teams, ensuring transparency and ongoing support

Ultimately, a Clinical Trial Project Manager acts as the glue that holds clinical trials together.

Roles at ICON: Clinical Trial Manager jobs

Clinical Trial Project Manager careers can be highly exciting and rewarding. The roles we have available at ICON allow individuals like you to become part of our shared mission to save lives and improve the quality of life for millions of people around the world. Whether you are just starting out or you are a seasoned Clinical Trials Manager , joining us will allow you to make a positive contribution.

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Clinical Trials

Inside a CRO: The Essential Role of a Clinical Project Manager

Lindsey Pierce

What is a Project Manager’s role in a clinical trial?

Clinical trials are the backbone of drug development, ensuring that new treatments are both safe and effective. In this intricate process, the Clinical Project Manager stands as a linchpin, ensuring the seamless execution of these trials.

Pharmaceutical and biotech companies who hire a Clinical Project Manager from Precision for Medicine gain a dedicated professional who ensures timely delivery, budget adherence, and risk mitigation, all while maintaining the highest standards of clinical research.

What makes for an effective Clinical Project Manager?

A Clinical Project Manager, often abbreviated as PM, brings a unique blend of skills and expertise to the table:

Strong attention to detail and organization: Ensuring every aspect of the trial is meticulously planned and executed.
Ability to track multiple deadlines and budgets: Keeping the trial on track financially and temporally.
Team leadership and collaboration abilities: Unifying diverse teams towards a common goal.
Excellent communication and interpersonal abilities: Bridging the gap between sponsors, teams, and other stakeholders.
Problem-solving and decision-making skills: Navigating challenges that arise during the trial.
Adaptability: Meeting the diverse needs and personalities of team members.
Comfort in challenging situations: Handling difficult internal and client conversations with tact and professionalism.

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What are the responsibilities of a Clinical Project Manager?

A PM’s responsibilities span the entire lifecycle of a clinical trial, ensuring every phase is executed to perfection.

Pre-award responsibilities

Supporting bidding and defense conversations to win the clinical trial.
Informing on bid strategies, including sites, patient enrollment, and overarching strategies.
Helping finalization of scope conversations, leading to clinical trial contract.

Responsibilities during study start-up

Contributing to the review and finalization of the trial protocol and related documents.
Creating the project plan and building the timeline.
Assembling the study team into a cohesive unit.
Assessing and recommending study vendors (if applicable for Sponsor at this stage).
Projecting patient enrollment and evaluating study timeline impact.

Responsibilities during the trial

Monitoring resourcing needs throughout the course of a trial.
Managing the trial budget and ensuring vendor success.
Recommending investigational sites and overseeing site activation timelines.
Reviewing and tracking risks for study timeline delivery, implementing risk mitigation strategies.
Ensuring quality data collection, protocol adherence, and patient safety.
Maintaining proper documentation practices for audit readiness.
Driving issue resolution and continuous process improvements.

Trial close-out responsibilities

Managing study closeout and ensuring the archival of study-specific documents.
Overseeing delivery of a clean and complete Trial Master File (TMF).
Coordinating the Clinical Study Report.
Evaluating final budget deliverables and ensuring all costs have been reconciled.

From study-start to finish: Journey of a Clinical Project Manager

What-does-a-clinical-Project-Manager-do-1024x576

Ensuring client satisfaction in communication and documentation

During the trial, the PM plays a pivotal role in maintaining a harmonious relationship between the CRO and the Sponsor. This is achieved by:

Developing budgets and additional timelines that are realistic yet aggressive.
Proactively identifying potential delays and out-of-scope work.
Implementing proactive and reactive study challenge mitigations to keep the trial on track.
Forecasting work to evaluate the remaining budget of the study.
Motivating team members and investigators towards trial goals.
Ensuring all study communication and documentation has been filed in the Trial Master File.
Proactively identifying resourcing needs or gaps.
Aligning trial conduct with sponsor strategic objectives.
Maintaining constant communication with the sponsor to ensure client satisfaction and study team improvement.

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Key Considerations for Selecting a CRO Partner

Dec 13, ‘22

Clinical Project Managers are indispensable in balancing the health of a clinical study and ensuring its success. Their expertise, dedication, and meticulous approach ensure that drugs are brought to market efficiently, benefiting the industry as a whole and, most importantly, the patients awaiting new treatments.

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WELCOME TO THE CLINICAL RESEARCH PROJECT MANAGEMENT ASSOCIATION

The Clinical Research Project Management Association (CRPM) is a global professional organization dedicated to uniting clinical research professionals who employ project management tools and methodologies to ensure the successful completion of project deliverables on time and within budget. Our mission is to foster connections, promote continuous learning, and enhance the well-being of Clinical Research Project Managers worldwide.

Join us today and become a part of the CRPM community, where you’ll find endless opportunities to connect, learn, and grow.

Welcome to a brighter future in Clinical Research Project Management!

Connect with the CRPM Community

At CRPM, we believe that networking is a vital part of professional growth. We facilitate connections between our members through various channels, including online groups, in-person meet-ups, monthly webinars, and retreats. By expanding the CRPM network, we aim to create a supportive and resourceful community that spans the clinical research industry. We invite you to join us and experience the power of connection and collaboration.

BECOME A MEMBER

Becoming a member of CRPM grants you access to a thriving community of clinical research project management professionals, along with a wealth of resources, networking opportunities, and educational events designed to support your career growth. Joining CRPM empowers you to stay ahead in the industry, expand your professional network, and continuously develop your skills and knowledge.

GET INVOLVED

By getting involved with CRPM as a volunteer or ambassador, you have the opportunity to make a meaningful impact within the clinical research project management community while developing your leadership and collaboration skills. Your contributions will help shape the future of the profession, foster a supportive environment for fellow members, and further establish CRPM as a leading organization in the field.

EVENTS CALENDAR

CRPM events, such as webinars, in-person meet-ups, annual conferences, and retreats, provide members with diverse opportunities to learn, network, and engage with fellow clinical research project management professionals. These events not only foster a sense of community but also help members stay current with industry trends, enhance their skills, and grow professionally.

Empower Your Career through Education and Professional Development

Unlock the full potential of your clinical research project management career by joining CRPM, where you will gain access to a wealth of tools, templates, and cutting-edge resources specifically curated for professionals like you. Don’t miss this opportunity to elevate your expertise and stay ahead in the rapidly evolving field of clinical research project management.

PROFESSIONAL DEVELOPMENT

Professional development articles offer valuable insights and practical advice to help CRPMs stay informed on the latest developments and best practices in their field. By regularly engaging with these articles, professionals can enhance their skills, broaden their knowledge, and ultimately excel in their roles.

CRPM ARTICLES

Our extensive library of articles covers a wide array of topics related to clinical research project management. These articles provide valuable insights and practical advice to help our members stay informed and up-to-date on the latest developments and best practices in the field.

CRPM TOOLKIT

The CRPM toolkit is a carefully curated collection of resources, templates, and best practices designed to help clinical research project managers streamline their work and optimize project outcomes. By utilizing this toolkit, members can enhance their efficiency, reduce project risks, and drive success in their clinical research projects.

Health and Wellness: The Key to Success

CRPM understands that the well-being of our members is essential for their overall success. We recognize that CRPMs are not just productivity engines, but whole individuals with unique needs and challenges. To address this, we feature health and wellness initiatives, such as stress management techniques, work-life balance strategies, and self-care practices tailored to the needs of CRPMs. By promoting a healthy lifestyle and fostering a culture of well-being, we empower our members to become the best versions of themselves, both professionally and personally.

HEALTH & WELLNESS ARTICLES

The health and wellness articles featured by CRPM address the unique challenges faced by clinical research project managers and offer practical advice on maintaining a balanced, healthy lifestyle. These articles promote self-care, stress management techniques, and work-life balance strategies, empowering CRPMs to succeed both professionally and personally.

ANNUAL RETREAT

Our annual retreats offer an immersive experience for CRPMs to connect with fellow professionals in a relaxed and inspiring setting to recharge, grow, and create lasting memories . Through workshops, team-building activities, and networking sessions, attendees can deepen their connections and foster long-term relationships with other members of the CRPM community.

HEALTH & WELLNESS EVENTS

CRPM’s wellness and health webinars and in-person events are designed to address the unique needs of clinical research project managers, promoting a balanced and healthy lifestyle. These programs provide practical guidance on self-care, stress management, and work-life balance strategies, enabling members to maintain their well-being while excelling in their professional roles.

Navigating Project Success with Scrum Methodologies

Scrum has emerged as a beacon of efficiency, collaboration, and adaptability in the ever-evolving landscape of project management methodologies. Originating from the agile framework, Scrum offers a structured approach to managing complex projects while fostering continuous improvement and flexibility. Whether you’re a seasoned project manager or a newcomer to the world of agile methodologies, understanding…

Continue Reading Navigating Project Success with Scrum Methodologies

How to Write a Professional Bio

Welcome to the world of clinical research project management, where your professional bio is more than just a formality—it’s a powerful tool to showcase your expertise and achievements. Whether you’re presenting at a conference, networking, or updating your online profile, crafting an engaging and informative bio is crucial. In this comprehensive guide, we’ll walk you…

Continue Reading How to Write a Professional Bio

What is Project Management?

Project Management is an essential skill set in various fields and industries. This article aims to introduce you to the multifaceted world of project management, providing a comprehensive insight into the roles, responsibilities, and key concepts involved. Whether you are looking to kickstart your career in project management or aiming to enhance your knowledge, this…

Continue Reading What is Project Management?

Understanding EIN: The Backbone of Your Business Identity

Every business needs a unique identifier, much like every individual needs a Social Security number. For businesses, this identifier is known as an Employer Identification Number (EIN), provided by the Internal Revenue Service (IRS). Let’s take a look at what an EIN is, why your business needs one, how to get one, and what to…

Continue Reading Understanding EIN: The Backbone of Your Business Identity

Mastering the Eisenhower Matrix

Keeping up with tasks and responsibilities can be a struggle when everything seems important. If you’re often caught in a whirlwind of to-do lists, it’s time to harness the power of the Eisenhower Matrix. This time management tool will help you decide, prioritize, and conquer your tasks more effectively. Let’s delve into the how-to of…

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Content Management System (CMS): Selecting the Right Platform

In the realm of business, establishing a strong online presence is as crucial as the research itself, especially for entrepreneurs stepping into this domain. A critical step in this journey is choosing the right Content Management System (CMS) for your website. A CMS is not just a tool to build a website; it’s the foundation…

Continue Reading Content Management System (CMS): Selecting the Right Platform

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Home // Clinical Project Manager

Clinical Project Manager

What does a clinical project manager do.

Being a Clinical Project Manager (CPM) in clinical operations means you are responsible for setting up, coordinating and leading clinical studies. This might involve medicines, medical nutrition or medical devices at a pharmaceutical company, a training hospital or a clinical research organisation (CRO). Often aided by an Assistant Clinical Project Manager, you lead a clinical project team of:

Clinical Trial Assistants (CTA);
Clinical Start-up Specialists;
Clinical Research Associates (CRA);
Data Managers.

You also manage vendors such as central laboratories. You monitor the progress of your projects and provide regular updates to stakeholders, such as the sponsor or client. As a CPM, you will ensure that your project is completed on time, within budget and with the right quality!

CPMs may also be called Clinical Trial Managers (CTM) or Clinical Study Managers (CSM). CPM vacancies may be called ‘Clinical Trial Project Manager’ or ‘Clinical Research Project Manager’. Other levels and job titles may also be found such as ‘Senior Clinical Project Manager’, ‘Junior Clinical Project Manager’ or even ‘Freelance Clinical Project Manager’.

Take a look at the Clinical Project Manager vacancies to see which are the best fit for you!

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What responsibilities can you expect as a Clinical Project Manager?

In a CPM job, responsibilities cover a range of duties. These depend on the company, but will generally include:

initiating and managing clinical projects in accordance with all relevant guidelines, legislation and SOPs;
monitoring the progress of the clinical trial against the project plan and performance indicators for quality and budget;
identifying risks, and developing and implement plans to mitigate risks in collaboration with team members and other stakeholders;
acting as a daily point of contact for the sponsor and members of the project team;
developing research-specific documents, trial master files (TMF) and electronic trial master files (eTMF);
reporting progress to the internal project team and stakeholders;
negotiating contracts with research centres and suppliers;
managing project finances in accordance with the sponsor contract and budget;
providing input for proposals and budgets, and in bid defence meetings.

Need more details? Browse our Clinical Project Manager vacancies

What education and skills do you need as a Clinical Project Manager?

CPM skills and educational requirements mean that you need to tick these boxes:

a bachelor or master’s degree in a Life Science;
excellent communication, negotiation and organisational skills;
good communication skills in English;
experience with managing a budget and a team;
leadership skills – a ‘helicopter’ view;
knowledge of good clinical practice (GCP) and project management (PMP certification).

Experience as a CRA on top of this would give you an edge.

What salary can you expect as a Clinical Project Manager?

Your salary as a CPM depends on your experience and the size of the project(s). In general, salaries in the Netherlands range from €60,000,- per year to more than €100,000. There may also be benefits such as a performance-based bonus or a lease car.

Do you want to know more about positions as a Clinical Project Manager?

View our list of Clinical Project Manager vacancies

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Clinical Project Manager Duties and Responsibilites

Primary duty.

A Clinical Project Manager (CPM) is responsible for a variety of tasks in their job scope. The specific responsibilities may vary depending on the company, but typically involve:

1. Initiating and overseeing clinical projects in adherence to established guidelines, legislation, and standard operating procedures (SOPs).

2. Monitoring the progress of the clinical trial by comparing it against the project plan and evaluating performance indicators related to quality and budget.

What is the difference between clinical project managers and research coordinators?

Clinical project managers in the pharmaceutical industry receive the highest salary among other roles, with an average salary of $103,836.

Research coordinators also earn comparable salaries, considering their educational qualifications, in comparison to clinical project managers.

Administrative Functions

A Clinical Research Project Manager (CRPM), also referred to as a Clinical Research Manager or Clinical Trial Manager, is responsible for providing leadership in the clinical trial of new drugs. The objective of a CRPM is to ensure the completion of the clinical trials process.

The role of a CRPM is crucial in overseeing the various aspects of clinical research, including study design, participant recruitment, data collection and analysis, adherence to protocols, and ensuring regulatory compliance.

By effectively managing the clinical trial process, a CRPM contributes to the advancement of medical research and the development of safe and effective drugs for patients.

The clinical project manager is responsible for overseeing the activities of the clinical operations team, including supervising team members. Their role includes planning, organizing, and directing personnel involved in clinical research projects to ensure alignment with clinical goals and objectives.

What does a project manager do?

Project managers have the crucial role of planning and supervising projects to ensure their timely completion and adherence to budgetary constraints. They are responsible for allocating project resources, organizing budgets, tracking progress, and keeping stakeholders updated throughout the process. These tasks are carried out in alignment with the company's overall goals and vision.

A Clinical Project Manager is a specialized type of project manager who works specifically in the field of clinical research or healthcare. Their responsibilities include overseeing and managing clinical trials, ensuring compliance with regulatory requirements, coordinating with research teams, and managing the various aspects of the project, such as timelines, budgets, and communication with stakeholders.

Overall, the role of a Clinical Project Manager is critical in ensuring the successful execution of clinical projects while adhering to industry regulations and meeting the goals of the healthcare organization.

Role in Decision-making Process

The Massachusetts Hospital Association emphasizes the importance of project management in healthcare by highlighting its ability to proactively mitigate risks during project completion.

Given the complex nature of healthcare projects, which are subject to regulatory limitations and involve multiple stakeholders, project management becomes even more necessary in this industry.

Performance Metrics

Clinical trials are an essential tool for improving patient outcomes when carried out with accuracy and efficiency. Playing a crucial role in this process, clinical project managers are responsible for ensuring that these trials are conducted in a timely manner, gather reliable data, and yield precise results. The role of a clinical project manager involves overseeing various aspects of clinical trials to ensure their successful execution.

Are clinical research management jobs keeping pace with the demand?

Clinical research management positions may not be meeting the increasing demand for clinical trials. According to the Bureau of Labor Statistics (BLS), employment opportunities for medical and health services managers are projected to grow by 32% from 2019 to 2029.

So, what exactly does a clinical project manager do? Wake Forest University explains that they are responsible for overseeing and coordinating the various aspects of a clinical trial. This includes developing project plans, managing budgets, ensuring regulatory compliance, and collaborating with various stakeholders involved in the research.

What are quality metrics?

There is no industry-wide standard for defining quality metrics. These metrics can be defined in different ways, such as measuring performance against a quality standard, predicting or influencing quality through operational activities, or ensuring compliance with quality regulations.

Manager Jobs

Clinical Project Manager Job Description, Duties, and Responsibilities

This post presents exhaustive information on the clinical project manager job description, including the key duties, tasks, and responsibilities they commonly perform.

It also highlights major requirements you may be expected to fulfill to be hired for the clinical project manager role by most recruiters/employers.

What Does a Clinical Project Manager Do?

A clinical project manager plays a huge and very important role in a clinical trial procedure.

The clinical project manager job description entails a wide range of functions to assist in conducting clinical research studies.

In some cases, he/she is also responsible for supervising the activities of clinical operations team members.

The role of the clinical project manager involves planning, organizing, and directing the activities of personnel involved in clinical research projects to make sure that they are in line with general clinical goals and objectives.

His/her duties also include review of medical records, interviews, screenings, and discussions with physicians so as to assess and ascertain the eligibility of potential subjects.

The manager is in charge of the management of all aspects of clinical trial and the selection of vendors so as to guarantee the safety of patients, non-breaching of contract, procedures, and data integrity.

He/she acts as the primary contact for vendors and leads in planning and communication with diverse study teams to make sure that trials are conducted and executed effectively.

He/she is also responsible for the preparation and review of all documents that are related to clinical projects, which includes contracts, vendor budgets, and annual reports.

Teams being supervised by clinical project managers usually include clinical research associates and clinical documentation specialists.

Their work description also entails taking part in the analysis, summary, and reporting of data for regulatory needs.

The manager in charge of clinical projects must make sure that required resources are available for any given project and must be able to settle issues that may come up in the process of executing a project.

He/she may also monitor, assess the performance of clinical team members, and train them on the daily operations of the project.

He/she must also try as much as possible to maintain a good relationship with study sponsors, external consultants, and the medical research team.

In a bid to achieve this, the manager will have to serve as a middleman between study sponsors and the clinical research team.

Clinical Project Manager Job Description Example/Template

Clinical project managers perform various functions to see to the commencement and successful completion of clinical research studies.

The job description example below shows typical tasks, duties, and responsibilities performed by individuals who work as clinical project manager in most organizations:

Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines
Prepare, oversee, and review documents that are related to assigned clinical study
Arrange or help in organizing clinical study meetings
Ensure the availability of necessary resources for the execution of clinical projects
Review and approve invoices being presented by study vendors and external consultants
Answerable to questions and issues brought up by vendors and external consultants
Help in the training and development of clinical staff as at when due
Lead the clinical project team and various study team meetings
Oversee the pattern and manner in which clinical research study is being conducted
Fully involved in resolving issues; take part in procedure improvement initiatives
Attain clinical study’s goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process
Work hand-in-hand with clinical trial managers and document control personnel to manage documents that are related to the clinical study.

Requirements – Abilities, Skills, and Knowledge – for Clinical Project Manager Role

To be hired for the role of a clinical project manager, some of the major requirements, including competence and qualifications you may be asked to possess by most employers include the following:

Must possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external persons like vendors and external consultants
Good problem-solving, organizational, and leadership skills are highly required
Ability to work with little or no supervision
Ability to pay keen attention to detail at all times
Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects
Must be able to work as part of a team or in most cases lead a team
Must have a ‘one of a kind’ work ethic, and must exhibit a great level of self-discipline
Ability to organize and motivate other members of the study team
A Bachelor’s and/or a Master’s degree in any science or health related field
A minimum of 5 years experience in the field of clinical research of which 2 years must have been in a project lead role
Proficient user of basic computer applications for the execution of daily project operations
Experience in writing clinical study procedures and other clinical document is a plus.

Are you an employer hiring for the position of clinical project manager? If you are, then you can apply the sample work description provided in this article to make one for the role in your organization.

You can make a detailed clinical project manager description that can help attract the best qualified candidates to your offer by using both the duties and responsibilities and the sample job description presented in this post.

Individuals hoping to start a career in the clinical project management field will also find this post helpful in learning about the job and the skills and qualities needed to succeed in it.

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Home > Resources > Healthcare Analytics > Clinical Research Manager Job Description

Clinical Research Manager Job Description

a female lab technician looking into a microscope

Published July 26, 2017
Updated May 2, 2024

Clinical research managers hold one of the most critical jobs in the healthcare industry, overseeing all aspects of clinical trials that evaluate new medications and medical devices.

People in these positions carry the responsibility for making sure the trial is conducted under very strict, very specific guidelines.

The job carries a great deal of responsibility. Clinical trials are a vital part of the development of any new medication or medical device, and companies often have their future riding on the outcome. Clinical trial managers not only oversee the trial, but also act as liaison between the trial site and the clinical study sponsor.

It’s a difficult job, but one that can provide a rewarding, stable and often lucrative career.

What Clinical Research Managers Do

When a company develops a new healthcare product, they must meet government regulations before being allowed to sell their product on the market. This means conducting clinical trials that determine whether the product does what its developers say it’s going to do, as well as ensuring that the product is safe for use.

Clinical research managers have a variety of duties associated with such trials. They include:

Planning and overseeing the trial
Determining whether a product accomplishes the goal for which it was produced
Ensuring the product meets all government regulations and standards
Managing a team of clinical research associates and specialists
Training clinical research team members and evaluating their performance

In addition, clinical research managers communicate with trial sponsors, keeping them updated on progress.

Skills and Education Needed

Working as a clinical research manager requires a mix of skills. They include leadership in guiding the research team, communication skills with both the team and study sponsors, as well as the technical skills needed to successfully plan and execute a clinical trial.

The people in this field come from various backgrounds. They typically have at least a bachelor’s degree in a field related to their clinical work, ranging from biology to life sciences and bioengineering. Attaining the manager position almost always requires a master’s degree or doctorate.

The ability to write study protocols and other research-related documents is key, as is expert-level knowledge in clinical trial practices and regulations. Project management skills also can prove beneficial for clinical research managers, given the complexity of the job and requirement to lead cross-functional teams.

Typically, those who become research managers also have years of experience at lower levels of the operation, including research specialists.

*National long-term projections may not reflect local and/or short-term economic or job conditions, and do not guarantee actual job growth. Information provided is not intended to represent a complete list of hiring companies or job titles, and program options do not guarantee career or salary outcomes. Students should conduct independent research for specific employment information.

While still an emerging field, health analytics consultants are increasingly becoming a popular career choice for healthcare professionals.

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What to know about project management for clinical trials.

A person sitting at a desk works on clinical trial project management

Completing any multi-part task requires organization, coordination, and discipline — and, of course, clinical trials are no exeption. Planning a research study, launching a trial, and keeping things running smoothly requires knowledge and expertise, which is why clinical trial project managers are so vital to the process.

From creating a plan, communicating updates, calculating risks, and addressing any mistakes that arise , solid project management is a necessity to ensure medical research is allowed to move forward. Here, we’ll discuss the role of the clinical trial project manager, as well as tips for developing project plans, stakeholder involvement, communication, IRB submission, and summarizing lessons learned.

What is project management in clinical trials?

The Project Management Institute (PMI) defines project management as the "application of knowledge, skills, tools, and techniques to project activities to meet the project requirements." Project management combines expertise in scope, time, cost, quality, risk management, communication, and stakeholder management in order to move through the five basic phases of any project :

Project initiation. This phase involves developing an idea, understanding the necessity of the project, and identifying the key decision-makers
Project planning. This is the phase for making a plan and outlining the work required, including prioritization, budget, schedule, and resources
Project execution. This is where tasks are distributed by informing all teams of their responsibilities and deadlines
Project monitoring. This entails implementing project tracking to compare the current project status and progress with the original plan, adjusting as needed
Project closure. The final phase, where project managers reflect on project success and key learnings for next time

When concerning clinical trials, project management brings all of these phases together to ensure set up, enrollment, operations, and reporting are all done smoothly and effectively.

Roles of a clinical trial project manager

A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below.

Vendor selection: Because conducting a clinical trial requires many different elements, outside vendors will often be brought in to provide expertise in certain aspects of a study. This is most common for specialized elements such as Interactive Web Response Systems (IWRS) , electronic patient-reported outcome (ePRO) technology, and clinical trial patient recruitment . Often, it will be the project manager's job to vet these vendors and assist with comparing options.

Timeline and budget oversight: Though every study begins with a specific timeline and budget, nearly 80% of all clinical trials are delayed due to difficulties in patient recruitment, which causes many to exceed their budget. In these situations, a project manager can leverage their expertise to hold the trial team accountable for the time and money spent on the study, in addition to managing expectations should these elements begin to change.

IRB submissions: Any patient-facing materials involved in research studies must be reviewed and submitted for Institutional Review Board (IRB) approval, and gathering these materials is often the responsibility of the clinical trial project manager. Because every IRB is different, the project manager will need to look at previous submissions and any templates that are available to ensure the study's particular IRB requirements are met.

Report generation: As part of tracking the progress of a trial, clinical trial project managers should regularly generate and distribute reports on various aspects of a study’s progress. These reports can often be automated so they are not a time-consuming task, but they do play an essential role in keeping key stakeholders looped in on the progress of the research.

Meeting coordination: Occasionally, the trial’s key stakeholders may need to meet to review a trial’s progress and address any roadblocks. The project manager will likely be charged with planning and leading these meetings to ensure that all details are covered and relevant updates are provided.

Tips for effective project management in clinical trials

Create a detailed project plan

One of the best ways to circumvent delays and issues in a clinical trial is to create a detailed project plan before the study launches. This plan should include a timeline of milestones, key dates, a task schedule, and any other relevant pieces that can keep the project on track. Some people may prefer pen and paper for this, but there are also many online resources available to help project managers keep track of details and stay on schedule.

Anticipate risk management demands

Every project will have some level of risk, so it’s wise to acknowledge what points of contention may arise and plan accordingly. A few examples of risks associated with clinical trials include:

Long wait times for IRB approval
Delays in patient recruitment
Turnover among site staff
Changes to the trial protocol

Before the project starts, it can be helpful to come together as a team to discuss potential risks that may arise, share past experiences, and determine how they can be prevented or handled if they do arise.

Understand IRB requirements

In most studies, the project manager will also be tasked with gathering materials and submitting them for approval from the Institutional Review Board (IRB). Every IRB will vary on its guidelines, but IRB administrators should be able to answer any questions to ensure a smooth and efficient process.

Even if the responsibility of IRB submission is a task for the project manager, it can be helpful to enlist additional team members to provide a second set of eyes before the materials are submitted. It is also wise to create a checklist of elements that should be included in the IRB packet to ensure nothing gets left out.

Foster open communication between sites and sponsors

Another important communication piece for project managers is to share feedback from sites back with the sponsor of the trial. Communication is particularly important in relation to sharing updates with sponsors about recruitment or screening challenges the site may be facing.

Communication tips for project management

One of the most important jobs of a clinical trial project manager is to ensure clear and effective communication with multiple stakeholders. To manage this communication from the onset, it can be useful to create a list of stakeholders, the updates they'll need, and how often they should be informed.

To manage this communication, the RACI project management method can provide a helpful framework to organize stakeholders into four categories based on their involvement in the project and communication needs.

Responsible: The responsible party is the main point person for communication – this is the stakeholder who does the actual work of this part of the project. For example, when submitting outreach material to the IRB, the person responsible for creating the material may be the lead on the marketing team or the contact at a clinical trial recruitment company.
Accountable: The accountable person is generally the manager of the responsible party and may wish to be involved in only some of the updates related to the project. Generally, if the responsible party needs approval from their manager, they should do so before sharing updates more broadly.
Consulted: The consulted party would be any additional stakeholders who should weigh in on a project. The responsible or accountable party can generally help project managers determine who should be involved in the consultation.
Informed: These are people who are simply kept up-to-date on the progress of the project at appropriate intervals.

A paper on managing clinical trials published by the National Institutes of Health also mentions the importance of keeping the investigators themselves in the loop about a trial, stating, "Investigators need to feel valued and part of an inclusive team answering an important clinical question, so providing regular feedback that ensures they feel involved must be central to a trial's communication strategy." Because the investigators may also have busy clinical practices in addition to being part of the trial, it’s important to respect their time while making them feel involved and informed.

Project managers’ roles after a clinical trial

Project management is an ever-evolving skill and there are lessons to be learned from even the most successful project execution. It’s important that project managers evaluate each trial after it's complete in order to analyze trends and plan for the next one while key learnings are still top of mind. As Hubspot puts it, "a productive project post-mortem is a chance to fully unpack a project's trajectory and dig deeper into why things unfolded the way they did.”

Hosting a project post-mortem meeting involving key stakeholders is advisable. Sending a pre-meeting questionnaire can streamline the process of gathering thoughts on what went well, what didn't, and what could be done better next time. The agenda should include a recap of the project's goals and a review of the results so that any discrepancies can be addressed and everyone is able to come up with actionable takeaways for the future.

If you're interested in learning more about how Antidote begins the clinical trial recruitment process and manages the project throughout, download our recruitment template below.

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Clinical Project Manager

Clinical trial management certification.

Demo Clinical Project Manager Training

Research Project Manager Certification

CCRPS Research Manager Graduates obtained job roles including:

Clinical Trial Project Manager, Research Nurse Manager, Clinical Research Coordinator-Data Manager, Clinical Research Associate, Transdisciplinary Research Project Manager, IT Project Manager in Clinical Research, Publicly Funded Research Project Manager (2024 CCRPS Graduate LinkedIn Survey).

Clinical Research Project Manager Training

Advanced Clinical Research Associate Certification (ACRAC)

Introduction

CME Handout

Common Terminology Used In Clinical Research - Reference Glossary

Commonly Used Abbreviations and Terms in Clinical Research

An Overview of ICH GCP

CFR 21 Part 11

Ethics of Research Involving Children

Ethics of Research Involving Mentally Incapacitated

Ethics of Research Involving Pregnant Women and Fetuses

Fundamentals of Project Management

Project Management Fundamentals

PMBOK Summary - Mandatory Project Management Review

Clinical Trial Project Management

Importance of Project Management

Roles and Relationships in Clinical Trials

Role of a Project Sponsor

ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

Data Safety Monitoring board- DSMB

Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

Contract Research Organizations (Delegation, Responsibilities, Management )

ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

Skills of a Project Manager

Essential skills of a Project Manager

Technical skills for Project Management

Project Team

Managing a Project Team

Project Management Documents

Regulatory Documents

Regulatory Documents in Clinical Trials

Delegation of Authority Log – DOAL

Investigators Brochure (IB)

Trial Master File

Essential Regulatory Documents Binder Tab Organization (Trial Master File)

Trial Master File Reference Guide

New Drug Application

The Investigational New Drug (IND) & New Drug Application (NDA) Process

Investigator Initiated Multi-Center Trials

IND and IDE AE Reporting

Safety Reporting Requirements for Sponsor Investigators of An IND

Problem Solving in Project Management

Problem Solving as a Project Manager

Project Failures and Statistics

Project Reporting Styles

Avoiding Project Failure

Budgeting for Clinical Trials and Projects

Project Budgeting

Payments and Budgeting for Investigators and Site

Advertisement Aid in Subject Recruitment and Retention

Clinical Trial Design

Advanced Designs of Clinical Trials

Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

Blinding and Unblinding in Clinical Trials

The Clinical Trial Protocol - Advanced Mastery Review

Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

Project Management Scheduling and Tracking

Basics of Project Scheduling

Project Progress Tracking

Project Management Planning Process

Project Management Plan

Closing a Project

Project Delays

Process Mapping

Metric Tracking

Duties of a Successful Project Manager

Roles and Responsibilties of a Project Manager

Project Management Success Factors

Adverse Events

Advanced Review of Adverse Events

Site Selection and Visits

Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

Audit and Inspections

Audits and Inspections in Clinical Trials

Clinical Trial Data Audits

FDA Warning Letter

Quality Control and Safety

Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

ICH GCP - Safety of Human Subjects in Clinical Research

Technology in Trials (IVRS, CTMS, EDC)

Clinical Trial Management System-CTMS

ICH GCP - Trial Management, Data Handling, and Record Keeping

An Overview of Remote Monitoring - COVID-19 Update

Centralized Monitoring

Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

Pharmacovigilance and Regulatory Affairs

Advanced Practice of Pharmacovigilance

Regulatory Affairs for Clinical Trials

Investigational Product and Labs

Investigational Product Storage and Dispensing

Investigational Product Accountability in Clinical Trials

Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

Patient Recruitment, Retention, and Compliance

Patient Recruitment in Clinical Trials

Patient Engagement and Retention in Clinical Trials

Patient Adherence and Compliance in Clinical Trials

Project Manager Job Readiness

Project Manager Skills Interview Questions

Interview Questions

Competency Examination

Competency Exam

About this course

Required: Prior clinical research or project management experience.
Length: 100 hours. Online, self paced, start anytime.
ACCRE, Joint Accreditation with AMA, ANCC, ACPE for 17.5 CME. Online certificate. Exam score 70% or higher on 2 attempts.

Enroll Schedule Advising

CCRPS Reviews

Clinical Research Project Manager Certification

Navigating the Course

Natalie johnson.

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and lear...

I was originally intimidated by the materials and all that I had to learn. The syllabus, the instructors and the course material were easy to follow and learn from. I am very happy I completed the course.

Advanced Clinical Research Project Manager Certification ...

Roger andersen.

There is extensive material in this course. It is highly relevant to managing clinical trials.

Advanced Clinical Research Project Manager

Ellen lyrtzis.

The clinical trial project manager is responsible for different aspects of the clinical trial process, such as setting timelines, developing budgets, and overseeing data analysis. To become a clinical trial manager, you can gain experience in project management or clinical research roles. Clinical trial manager certification will increase your chances of getting hired.

To become a clinical project manager, one must first obtain a Bachelor's degree in a health-related field. Additionally, developing skills for project management and participating in relevant courses are necessary.

Experience can be gained by volunteering or interning in clinical trials with pharmaceutical companies or medical research centers.

Pursuing an advanced degree or getting certified as a Clinical Project Manager with open up more opportunities.

Clinical Trial Manager

Clinical Trial Managers are responsible for planning and overseeing all aspects of clinical research projects. This includes making sure the project is conducted according to regulations and best practices. They also manage budgets, timelines, and resources to ensure the project is completed successfully.

Clinical Project Managers plan and execute clinical research projects by coordinating with internal and external stakeholders, regulatory authorities, and by develop key documents like protocols, consent forms, investigator brochures, budget sheets, study reports, and final reports.

Clinical Research Manager

Clinical Research Managers make sure that data is being collected and analyzed correctly, and that everyone is compliant. Clinical Project Managers design research studies and monitoring projects in terms of cost, budgeting, quality assurance, and risk assessment.

The Clinical Trials Management Certificate program is designed to provide students with the knowledge and skills necessary to design, implement, and manage clinical trial protocols.

This Clinical Trials Design & Management Certificate Program introduces learners to the fundamentals of clinical trials design and management.

The program covers principles and regulations of clinical trial design, analysis techniques for statistical analysis, quality control and assurance, data management and reporting.

Students will also gain an understanding of risk assessment strategies, study site selection, protocol implementation and monitoring, resource management as well as safety requirements for conducting clinical trials.

Clinical Trial Manager Salary

Clinical manager salary.

Clinical trial manager salaries vary based on experience, location, and company size. The average hourly rate for a clinical trial manager is $30-$60 per hour.

Clinical trial manager salary

The monthly salary of a clinical trial manager typically ranges from $5,000 to $10,000. Those with more experience or who work at well-known organizations can earn up to $20,000 per month.

Clinical project manager salary

Annual clinical project manager salary ranges between $60,000 and $120,000 dollars per year. The median salary for a clinical trial manager is approximately $82,500 across all industries and geographies

What does a Research Project Manager do?

Clinical Project Managers are responsible for creating project plans, timelines, budgets, and communication with vendors and stakeholders. They also provide training to personnel involved in the project, establish systems to track project progress, and identify risks associated with the project.

Clinical Project Managers make sure that clinical research projects go well by working groups like contract research organizations (CROs), internal departments, and external vendors. Clinical Project Managers make sure that projects follow the research protocols, good clinical practices (GCPs), applicable regulations, and standards.

Research Project Managers also develop protocols for data collection and analysis, prepare reports for regulatory submissions, coordinate activities related to safety monitoring, and provide support to staff during project-related training sessions or workshops.

Trial Project Managers make sure that data is collected accurately according to guidelines from the FDA or EMA. This includes finding risks associated with the project; assessing their impacts; planning ways to reduce the risks; and also planning how to use resources so that everything runs smoothly.

The most advanced clinical trial project management training available

Take the fast track.

Take the fast track to a lucrative career as a Clinical Research Project Manager to start earning salaries of $100k+

Get advanced training

Get the most advanced training - ACRPM is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

Work at your own pace

Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

Requirements

Designed for those holding a minimum of a BA in Science, ACRPM is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

ACRPM features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by clinical trial project managers, enabling students to build a deep knowledge of the industry.

Certification

This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a final exam. ACRPM also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position.

Clinical Project Manager Guide

Clinical Project Managers are responsible for clinical research activities and initiatives in the healthcare, pharmaceutical, and biotechnology sectors. This includes creating and implementing project plans, developing timelines, overseeing budgets, managing resources, and ensuring compliance with regulatory requirements. CPMs typically work with cross-functional teams that may include clinicians, scientists, regulatory affairs specialists, data management personnel, software developers/engineers, project sponsors/coordinators.

The career path of a Clinical Research Project Manager is very rewarding. You get to use your clinical research expertise to develop new treatments for existing medical conditions and to create new treatments for future medical needs. Additionally, you get to work with leading doctors, scientists, and other professionals who are working towards improving healthcare outcomes. You also have the opportunity to build relationships with key stakeholders including pharmaceutical companies, governmental agencies, and funding bodies which leads to greater satisfaction in your career.

Research project managers are responsible for planning and executing research studies throughout their entire life cycle. This includes activities such as designing experiments or surveys, selecting appropriate experimental methods or sampling techniques, recruiting participants for studies or surveys, collecting data from multiple sources, analyzing results using statistical methods or software programs, interpreting results and preparing recommendations for further action.

The clinical project manager definition refers to a professional who is in charge of developing clinical research activities from the beginning to the end. This includes making a plan for the scope and timeline of the research project; making sure that the project meets all regulatory requirements; organizing the technical aspects of data collection; coordinating meetings between stakeholders; monitoring progress and deadlines; utilizing risk management processes; providing guidance to staff members; ensuring quality control of data collection processes; providing reports to stakeholders and company executives regarding project status updates as needed.

Working as a clinical project manager can be challenging due to the complexity of the tasks involved. Clinical projects require significant planning, coordination and supervision between multiple stakeholders. Additionally, time management can be difficult due to deadlines that must be met and ever-changing regulatory requirements. Other challenges include managing competing priorities and ensuring proper communication between team members. It is also important for clinical project managers to stay current on trends, technologies and best practices within their field so that they can remain competitive in their work.

The core duties of a clinical project manager vary depending on the industry but typically include planning and organizing activities related to assigned projects; developing budgets; coordinating resources; monitoring progress; overseeing quality control standards; ensuring adherence to safety procedures; providing leadership for teams; communicating with stakeholders throughout the duration of the project; developing plans for corrective action if needed; preparing reports for upper management; analyzing data related to performance metrics; maintaining records of all activities related to assigned projects; and staying informed of changes in regulations relating to their area of expertise.

To be a good clinical project manager, it is important to have experience working in healthcare, like in a hospital. It is also helpful to be good at organizing and communicating, as well as understanding the medical environment and the rules that govern it. Additionally, clinical project managers should know about principles related to project management, like budgeting, scheduling, and risk management. Those who have earned a healthcare-related degree or certificate (like in nursing or health information management) may have a better chance of being successful in the role.

A clinical project manager oversees clinical research studies from design through implementation. This includes working with teams of physicians, pharmacists, nurses, statisticians or other health professionals. Responsibilities include making sure the project runs smoothly while staying within the budget and timeline. As part of their role they must understand FDA regulations when conducting trials in the US or ICH guidelines when conducting international studies. Additionally they must be able to identify potential risks associated with each study and develop strategies for mitigating them throughout all stages of the study process.

The average salary for a Clinical Project Manager is approximately $85,000 per year. Hourly pay for Clinical Project Managers usually ranges from around $41 to $58 per hour, with an average rate of approximately $49.50 per hour. Monthly salaries typically range from around $7,083 to $9,833 per month or more.

•Clinical Project Manager – Research and Development: This person is responsible for making sure clinical research studies are organized and run smoothly. • Senior Clinical Project Manager: This person provides guidance to project teams and management when they are developing clinical research projects. • Global Clinical Trial Program Manager: This person creates global clinical trial plans that meet operational requirements while following regulatory guidelines. • Clinical Data Management Project Manager: This person oversees all aspects of data collection, management, analysis and reporting associated with a clinical research project from start to finish. • Regulatory Affairs/Clinical Project Manager: monitors and reports on the regulatory submissions for clinical trials taking place in different countries. • Clinical Operations Project Manager:: oversees and coordinates the daily operations of clinical research projects to ensure that they meet quality assurance standards set out by IRBs or FDA .

Achieving certification as a Clinical Project Manager is a way to show that you are an expert in project management within the healthcare and medical research industries. This certification allows individuals to demonstrate their understanding of clinical project management concepts and skills, which are necessary for ensuring successful outcomes for initiatives within complex clinical research environments. To obtain a Clinical Project Manager Certification, you need extensive knowledge and experience in clinical project management, which can be obtained through formal education, training courses, and hands-on experience.

Certification as a clinical project manager provides healthcare professionals with the skills and knowledge necessary to effectively manage complex clinical trials, research projects, and quality improvement initiatives. There are several key reasons to get certified, including professional credibility, a competitive edge in the job market, increased knowledge base, improved efficiency in completing tasks related to clinical project management, and networking opportunities.

What They Do

What does a Clinical Project Manager do?

A clinical project manager specializes in developing and organizing clinical trials. Their responsibilities revolve around planning and coordinating with all necessary personnel and experts, scheduling meetings, and preparing necessary documentation, ensuring compliance with all laws and regulations. Moreover, a clinical project manager must devise strategies and train all staff, develop protocols and guidelines, coordinate with vendors and suppliers, evaluate staff and verify documentation, and assist in all activities to ensure that every process aligns with the project's agenda. Should there be any issues or concerns, a clinical project manager must conduct corrective measures right away.

Responsibilities
Skills And Traits
Comparisions
Types of Clinical Project Manager

Clinical project manager responsibilities

Clinical project managers play a crucial role in ensuring the success of clinical trials. They are responsible for overseeing the entire clinical trial process, from protocol development to study closeout. This includes managing study budgets, timelines, and resources, as well as ensuring compliance with regulatory requirements and good clinical practice (GCP) standards. Additionally, they are tasked with leading cross-functional teams and collaborating with sponsors, vendors, and other stakeholders to ensure the successful execution of clinical trials. As Lee Penn Ph.D. , Director of Undergraduate Studies - Chemistry Department, Merck Professor, and Professor at the University of Minnesota, puts it, "They want candidates with strong backgrounds in their majors PLUS two things - experience with data science, statistics, or some kind of computer science and soft skills (communication, playing well with others, collaboration, etc. This highlights the importance of both technical and interpersonal skills for clinical project managers.

Examples of clinical project manager responsibilities include "monitored clinical investigations by performing on-site visits to assure medical accuracy and compliance with protocol, ich/gcp guidelines and fda regulations," "managed two phase 2 GI studies - overall responsibility for clinical activities including site selection and monitoring," and "led protocol development and writing teams comprised of academic researchers, pharmaceutical industry and NIH personnel." These examples demonstrate the range of tasks that clinical project managers are responsible for, from monitoring clinical trials to leading protocol development teams.

Here are examples of responsibilities from real clinical project manager resumes:

Develop, manage, motivate and ensure professional development of project staff (13 CRAs).
Manage domestic and international oncology clinical study sites.
Manage multiple pharmaceutical studies ensuring compliance with FDA guidelines.
Manage the operational aspects and execution of clinical studies focusing on oncology.
Supervise rotating team of CRA's contract with the CRO, educating on therapeutic area, and ensuring ICH GCP compliance.
Ensure GCP / ICH regulatory compliance on studies, preventing study deviations and provide swift resolutions to possible violations.
Coordinate site initiation meetings, prepare IRB documents, develop documents and routing slips, and review protocols and consent forms.
Provide training via recurring sessions how to Manoeuvre the SharePoint template to i3 companies.
Initiate actions to ensure all assign investigative sites are in compliance with protocol and GCP.
Champion an incentive program to encourage use of services and bring more patients in for consulting.
Collaborate with sponsors, reader groups, stakeholders, vendors, clients, project staff and patients.
Work closely with internal team and CRO to ensure timely completion of studies, locking of database and statistical analysis.
Create CRFs for screening/enrollment/follow-up visits.
Handle direct communication with IRB for complete submission and maintenance of essential regulatory documents.
Provide direct supervision of clinical support staff and vendor qualification, selection, oversight and management.

Clinical project manager skills and personality traits

We calculated that 12 % of Clinical Project Managers are proficient in Manage Cross , Patients , and Clinical Research . They’re also known for soft skills such as Interpersonal skills , Leadership skills , and Problem-solving skills .

We break down the percentage of Clinical Project Managers that have these skills listed on their resume here:

Develop and maintain project schedule, identify and track milestones and identify and manage cross-functional dependencies.

Collaborated with sponsors, reader groups, stakeholders, vendors, clients, project staff and patients.

Manage Clinical research associate resignations and releases by working with clinical resourcing to ensure primary sites are covered and reassigned.

Presented on a monthly basis to senior management regarding departmental development and the status of ongoing project management initiatives.

Headed Clinical Trial Material Coordination and Communication team for effective planning of upcoming and existing clinical trials within Eli Lilly.

Ensured appropriate clinical safety assessment and risk management of compounds, conducted real-time medical oversight of ongoing trials.

"manage cross," "patients," and "clinical research" are among the most common skills that clinical project managers use at work. You can find even more clinical project manager responsibilities below, including:

Interpersonal skills. To carry out their duties, the most important skill for a clinical project manager to have is interpersonal skills. Their role and responsibilities require that "natural sciences managers lead research teams and therefore need to work well with others in order to reach common goals." Clinical project managers often use interpersonal skills in their day-to-day job, as shown by this real resume: "based on depth of experience and superb interpersonal skills, selected to train and mentor new clinical trials specialists. "

Leadership skills. Another essential skill to perform clinical project manager duties is leadership skills. Clinical project managers responsibilities require that "natural sciences managers must be able to organize, direct, and motivate others." Clinical project managers also use leadership skills in their role according to a real resume snippet: "provided leadership in redesign projects related to the coordination, design/redesign, delivery and management of patient care services. "

Problem-solving skills. This is an important skill for clinical project managers to perform their duties. For an example of how clinical project manager responsibilities depend on this skill, consider that "natural sciences managers use scientific observation and analysis to find answers to complex technical questions." This excerpt from a resume also shows how vital it is to everyday roles and responsibilities of a clinical project manager: "ensured gcp / ich regulatory compliance on studies, preventing study deviations and provided swift resolutions to possible violations. ".

Time-management skills. For certain clinical project manager responsibilities to be completed, the job requires competence in "time-management skills." The day-to-day duties of a clinical project manager rely on this skill, as "natural sciences managers must be able to perform multiple administrative, supervisory, and technical tasks while ensuring that projects remain on schedule." For example, this snippet was taken directly from a resume about how this skill applies to what clinical project managers do: "assisted in designing protocols regarding primary and secondary outcome variables, follow-up schedules, and data collection timelines. "

Communication skills. Another common skill required for clinical project manager responsibilities is "communication skills." This skill comes up in the duties of clinical project managers all the time, as "natural sciences managers must be able to communicate clearly with a variety of audiences, such as scientists, policymakers, and the public." An excerpt from a real clinical project manager resume shows how this skill is central to what a clinical project manager does: "lead discussion meetings for preparation of briefing document and special protocol assessment communications with fda. "

Most common clinical project manager skills

The three companies that hire the most clinical project managers are:

Organon 475 clinical project managers jobs
QuintilesIMS 138 clinical project managers jobs
Laboratory Corporation of America Holdings 130 clinical project managers jobs

Choose from 10+ customizable clinical project manager resume templates

Compare different clinical project managers

Clinical project manager vs. senior research associate.

A Senior Research Associate works closely with research team members to implement research ideas. They diagnose, solve system/software problems, and install application software according to research needs.

There are some key differences in the responsibilities of each position. For example, clinical project manager responsibilities require skills like "manage cross," "clinical research," "oversight," and "clinical operations." Meanwhile a typical senior research associate has skills in areas such as "crispr," "molecular biology," "cell culture," and "flow cytometry." This difference in skills reveals the differences in what each career does.

Clinical project manager vs. Research nurse

A research nurse specializes in conducting studies and scientific research for healthcare and medical development. They may work for medical facilities, private clinics, learning institutions, and government agencies. It is their duty to design research strategies and procedures, gather and analyze samples through various scientific methods, coordinate with other experts, and develop treatment and healthcare plans to optimize patient services and outcomes. Moreover, a research nurse typically works with a team of researchers, which requires an active communication line while adhering to the organization's policies and regulations.

In addition to the difference in salary, there are some other key differences worth noting. For example, clinical project manager responsibilities are more likely to require skills like "manage cross," "clinical research," "project management," and "clinical trials." Meanwhile, a research nurse has duties that require skills in areas such as "research projects," "clinical care," "vital signs," and "human subjects." These differences highlight just how different the day-to-day in each role looks.

Clinical project manager vs. Research coordinator

A research coordinator is responsible for assisting the development of research data from clinical trials and laboratory investigations under the supervision of a lead researcher or a research supervisor. In some cases, research coordinators conduct field investigations and analyze existing research materials upon understanding the scope and limitations of the study. They enter their findings and useful resources on the research database for reference to the research team. A research coordinator must have excellent communication skills , both written and oral, especially on gathering data and coordinating with other researchers for the progress and updates of the study.

The required skills of the two careers differ considerably. For example, clinical project managers are more likely to have skills like "manage cross," "clinical research," "project management," and "oversight." But a research coordinator is more likely to have skills like "research projects," "data entry," "human subjects," and "research data."

Clinical project manager vs. Study coordinator

Study coordinators oversee the entire process of clinical research from its inception to its completion. The coordinators make certain that human subjects are safe and well-protected. They identify the eligibility of the subject through clinical record screening and medical information extracting. It is their responsibility to maintain the regulatory documents based on the requirements of the Food and Drug Administration (FDA). They should develop skills and knowledge in clinical trials, study protocol, and patient care.

Types of clinical project manager

Project Manager
Practice Manager
Clinical Manager
Patient Care Manager
Clinical Director
Medical Manager

Updated April 25, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

What a Clinical Project Manager Does FAQs

How do i become a good clinical project manager, what qualifications do you need to be a project manager, search for clinical project manager jobs, what similar roles do.

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Olive View-UCLA Education and Research Institute

Clinical research project manager.

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We are looking for a Full Time Clinical Research Project Manager to manage our research team in the Department of Emergency Medicine Research Division at Olive View-UCLA Medical Center. Our team’s research focuses on the intersection of emergency medicine and infectious diseases affecting the community. Current activities include surveillance of mpox, observational study of antibiotic resistant bacteria in skin infections, and a clinical trial to determine best duration of antibiotic treatment for women with kidney infections,

RESPONSIBILITIES

Manage all active studies for OV-UCLA DEM research team under the PI’s and research director’s supervision
Recruit, hire and manage schedules and activities of OV-UCLA study coordinator staff
Manage the set up, implementation/data collection, data quality assurance, regulatory activities, and close out of all studies
Work with micro lab staff and research pharmacists as necessary to set up and implement specimen collection, testing, storage and study drug dispensing procedures for relevant studies
Ensure participant and staff compensation are set up, accounted for and tracked during study implementation
Train and retrain study coordinator staff as necessary
Schedule and run regular meetings with OV-UCLA study coordinator staff and PIs as necessary.

JOB QUALIFICATIONS

Excellent verbal and written communication skills, which may include business and technical writing, editing and proofreading.
Computer skills using PC platform computers with proficiency in Excel, Word, Access, Powerpoint.
Demonstrated organizational skills to efficiently and effectively provide management/monitoring support for multiple clinical studies and projects, providing accurate information in a timely manner.
Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information.
Demonstrated ability to prioritize workload to meet demands of above PI’s and supervisor.
Demonstrated knowledge of all components of the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data collection, etc.
Demonstrated interpersonal skills to work with patients, their families/ guardians, physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.

COMMENTS

What Does a Clinical Project Manager Do?
Clinical project management calls for expertise in subjects that facilitate ethical practices and effective research. Key knowledge for clinical project managers includes the following: Ethical research design, to ensure that the potential benefits of clinical trials don't outweigh the safety of participants. Risk management, to prepare for ...
What Does a Clinical Project Manger Do? Job Description & Roadmap
Clinical Project Managers (CPM) play a crucial role in advancing the progress of a clinical trial. The significance of CPMs lies in their ability to navigate complex clinical trials, ensuring precision, compliance, and efficiency. As stewards of the entire research lifecycle, from planning to execution, Clinical Project Managers wield strategic ...
How To Become a Clinical Project Manager in 6 Steps
Here's a list of six steps that you can follow when trying to pursue a career as a clinical project manager: 1. Earn a bachelor's degree. You can start pursuing a career in clinical project management by earning an undergraduate degree in an applicable field. Many clinical project managers have bachelor's degrees in biology, health, life ...
Clinical Research Project Management: Back to Basics
The following are three major reasons why project management in clinical research is important: Timeline management. Project management ensures the delivery of clinical trial objectives and sub-objectives within the allocated time and budget. This is important because nearly 85% of all clinical trials experience delays. [1]
What Does a Clinical Project Manager do?
Clinical Project Managers (CPM) play a vital role in the healthcare and pharmaceutical industries, overseeing the successful execution of clinical trials from inception to completion. This position bridges the gap between the scientific and administrative aspects of clinical research, ensuring that projects are carried out efficiently, within ...
What does a clinical trial project manager do?
They facilitate the smooth running of trials, ensuring the project team can focus on their area of expertise. They support clear communication between trial sponsors and project teams, ensuring transparency and ongoing support. Ultimately, a Clinical Trial Project Manager acts as the glue that holds clinical trials together.
Inside a CRO: The Essential Role of a Clinical Project Manager
A Clinical Project Manager, often abbreviated as PM, brings a unique blend of skills and expertise to the table: Strong attention to detail and organization: Ensuring every aspect of the trial is meticulously planned and executed. Ability to track multiple deadlines and budgets: Keeping the trial on track financially and temporally.
What does a clinical trial project manager do?
Clinical trial project managers are at the heart of research. They keep studies running on schedule, help manage budgets, choose and liaise between vendors, report on results, enforce compliance, and fulfill other key duties. Responsibilities and job titles vary (not all clinical trial projects have an official "project manager" with that ...
What does a Clinical Research Project Manager do?
Clinical Research Associate (CRAs) are responsible for coordinating and overseeing the execution of studies and clinical trials. They have a hand in everything from recruiting study participants to creating study documentation, collecting patient data, and performing quality assurance audits to ensure study protocols are being followed.
Clinical Research Project Manager
A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated ...
Common Questions For a Clinical Research Project Manager
CPM jobs involve planning and managing all aspects of a clinical trial. The aim of clinical trials is to evaluate the safety and effectiveness of pharmaceuticals, medical devices, or in-vitro diagnostic devices to support regulatory submissions or marketing claims. In order to manage a clinical trial adequately, CPMs manage a team of CRAs and ...
Association of Clinical Research Project Managers (ACRPM)
The Clinical Research Project Management Association (CRPM) is a global professional organization dedicated to uniting clinical research professionals who employ project management tools and methodologies to ensure the successful completion of project deliverables on time and within budget. Our mission is to foster connections, promote ...
What does a clinical research project manager do?
Learn what a clinical research project manager does, how they plan, coordinate, and oversee clinical trials, and what skills and challenges they face.
What does a Clinical Project Manager do? // Talentmark
Being a Clinical Project Manager (CPM) in clinical operations means you are responsible for setting up, coordinating and leading clinical studies. This might involve medicines, medical nutrition or medical devices at a pharmaceutical company, a training hospital or a clinical research organisation (CRO). Often aided by an Assistant Clinical ...
Clinical Project Manager Duties and Responsibilites
A Clinical Project Manager is a specialized type of project manager who works specifically in the field of clinical research or healthcare. Their responsibilities include overseeing and managing clinical trials, ensuring compliance with regulatory requirements, coordinating with research teams, and managing the various aspects of the project ...
Clinical Project Manager Job Description, Duties, and Responsibilities
What Does a Clinical Project Manager Do? A clinical project manager plays a huge and very important role in a clinical trial procedure. ... In a bid to achieve this, the manager will have to serve as a middleman between study sponsors and the clinical research team. Clinical Project Manager Job Description Example/Template.
Clinical Research Manager: Job Description and Overview
What Clinical Research Managers Do. When a company develops a new healthcare product, they must meet government regulations before being allowed to sell their product on the market. ... Project management skills also can prove beneficial for clinical research managers, given the complexity of the job and requirement to lead cross-functional ...
What to know about project management for clinical trials
A clinical trial project manager may have different responsibilities specific to each trial, but in general, they will be tasked with vendor selection, budget oversight, IRB submissions, report creation, and meeting planning, all of which are detailed below. Vendor selection: Because conducting a clinical trial requires many different elements ...
Clinical Project Manager Certification
What does a Research Project Manager do? Clinical Project Managers are responsible for creating project plans, timelines, budgets, and communication with vendors and stakeholders. They also provide training to personnel involved in the project, establish systems to track project progress, and identify risks associated with the project. ...
What does a Clinical Project Manager do?
Project managers are responsible for planning and overseeing projects to ensure they are completed in a timely fashion and within budget. Project managers plan and designate project resources, prepare budgets, monitor progress, and keep stakeholders informed the entire way. This is all done within the confines of a company's goals and vision.
What is a clinical project manager and how to become one
It typically takes 4-5 years to become a clinical project manager: Years 1-4: Obtaining a Bachelor's degree in a relevant field, such as science, business, or healthcare administration. Year 5: Accumulating the necessary work experience in clinical research, project coordination, or related fields.
The Career Path of a Clinical Research Coordinator
A clinical research coordinator is an integral part of the research team for medical studies. They conduct and manage clinical trials, providing outcomes that shape medical advances in preventative care, curing diseases, and immunizations, among other areas. With employment options available in hospitals, pharmaceutical companies, and private ...
What does a Clinical Project Manager do?
The annual salary of senior research associates is $27,892 lower than the average salary of clinical project managers.While the two careers have a salary gap, they share some of the same responsibilities. Employees in both clinical project manager and senior research associate positions are skilled in patients, project management, and clinical trials.
Clinical Research Project Manager
Clinical Research Project Manager. Recruitment began on March 8, 2024. Expires May 31, 2024. Full-time. Apply Now. We are looking for a Full Time Clinical Research Project Manager to manage our research team in the Department of Emergency Medicine Research Division at Olive View-UCLA Medical Center. Our team's research focuses on the ...