Skip to main content

What Does a Clinical Project Manager do?

Written by: Mike Wood / Lucy Walters
Published on: 12 Mar 2019

What Does a CPM 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.

Search the Latest CPM Jobs

Search the latest roles in Clinical Project Management on PharmiWeb.Jobs here.

Don’t forget to create an account and upload your CV to help recruiters find YOU, and to create job alerts to hear about the latest CPM roles as soon as they’re posted.

Article updated April 2024.