What Does a Clinical Project Manager Do?

Also known as Clinical Trial Managers or Clinical Study Managers, Clinical Project Managers (CPM) are responsible for planning and coordinating clinical research projects. They direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives.

What are the Main Responsibilities of a CPM?

The responsibilities of a CPM may vary, but often 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 Experience, Skills and Qualifications are Needed to Become a CPM?

Typically, to become a CPM you will need a bachelor’s or master’s degree in a life science, although this will depend on your employer. You may also need:

• Experience successfully managing a team.
• Experience working in Clinical Research, e.g., as a Clinical Research Associate (CRA).
• Good working knowledge of GCP.
• Excellent communication and negotiation skills.
• Strong organisation and time management skills.
• Adaptability to new tools, technology, and procedures.
• Excellent attention to detail to assess data accuracy and protocol compliance.
• Strong analytical skills to interpret study data.
• Experience in risk management.

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