What does a clinical research project manager do in clinical trials?

Clinical research project management

Clinical project management describes the function of project management in clinical studies. Clinical research project management involves the coordination and oversight of clinical research projects such as clinical trials or medical device trials. The role is typically responsible for overseeing all aspects of a study, such as planning, study/protocol design, budget and timeline management, and compliance and reporting.

Clinical project management duties could be tasked to a project management team for large-scale studies, but are usually assigned to an individual, who would have the title of clinical research project manager, sometimes also called clinical project manager (CPM) or clinical study manager (CSM). This role can also be called clinical trial manager (CTM) in certain organizations, although typically that is another role altogether who would report to the CPM (there is not necessarily a strictly defined hierarchy in organizations that sponsor clinical research).

Who employs clinical project managers?

Clinical project managers are typically employed by pharmaceutical companies who sponsor clinical studies, by hospitals or sites who conduct clinical trials, or by contract research organizations (CROs). If you are interested in becoming a clinical project manager or following a career path that may eventually lead you there, read on to learn more about what clinical project managers do, what important skills and qualifications would make someone excel in this position, and to find out about some clinical research project management courses and certifications.

What does a project manager do in clinical research?

The clinical project manager is responsible for ensuring that all aspects of a clinical study run smoothly, and may oversee study and protocol design, patient recruitment, study start-up, data collection and processing, and quality control. Important core responsibilities of the clinical project manager also include ensuring the study is conducted in compliance with applicable regulations and on track with the projected timeline, as well as facilitating communication between all stakeholders involved in a clinical research project and reporting on progress. The clinical project manager usually negotiates and manages contracts with external vendors and also manages the trial’s finances and budget.

Qualifications and qualities: What makes a great clinical research project manager?

Although most clinical project management positions require candidates to have a bachelor’s degree, many companies prefer those who have a master’s or Ph.D. Since this is a high-level position, candidates are usually expected to have direct experience in clinical research management, or at least a background in a field that is highly relevant to clinical research, such as medicine, life sciences, project management, or data science. Some employers also prefer candidates with degrees in management, such as an MBA, in addition to the above.

Successful clinical research project management requires a combination of specific skills, knowledge, and experience. Some of the main qualities that companies look for in clinical project managers include:

Organization and time management: Since a clinical project manager oversees numerous separate yet interconnected aspects or teams involved in a clinical study, they must have strong organizational skills. Time management is a related skill that is extremely important due to the dynamic nature of the tasks involved throughout the trial timeline, which include strict deadlines with regulatory agencies or stakeholders such as the sponsor.
Knowledgeable: A clinical research project manager should have strong knowledge in the relevant aspects of healthcare/medicine, health economics, and data management, so that they can understand the science behind the trial for informed decision-making.
Detail-oriented: When dealing with patients’ health, legal regulations, and large budgets involving multiple stakeholders, it is vital that the clinical project manager be attentive to details, as oversights or mishaps can have serious consequences.
Risk-management mindset: Related to the previous point, it is the responsibility of the clinical project manager to identify and mitigate any potential risks, either to patient health or to the quality of the trial (or both).
Communication skills: Communication is key to success in clinical trials. Project managers must be apt at facilitating communication between key stakeholders of different backgrounds, in order to ensure that trial tasks are on track and that everyone is in the loop. It is also central to networking and building relationships with sponsors, patients, trial sites, contractors, and vendors.
Financial management and planning: The clinical research project manager will have to manage (or oversee) the trial’s budget, making sure that all departments and tasks are allocated sufficient resources while leaving room for unexpected circumstances and ensuring that the overall trial is conducted within the sponsor’s budget.

Clinical research project management certifications

Beyond the appropriate studies and relevant work experience, you can also build-up your skill set by obtaining certifications or taking various courses, which can be conducted online or in-person. It is also worth noting that employers tend to view certifications as a sign of commitment to the profession and an indication that the candidate has a high level of field-specific knowledge.

There are a number of certification programs available around the world. For the US market, we have identified the following clinical research project management certifications that are highly relevant:

DIA is a prestigious global organization that promotes education, training, and networking of life science and healthcare professionals.

DIA is offering an intermediate-level online course in Clinical Project Management designed for clinical trial managers and clinical project managers, but in theory it could probably be taken by an ambitious aspirant to equip yourself with further skills to enhance your chances of landing a role as a clinical project manager.

They also offer a beginner-level “Essentials of Project Management” course, also online, which is also designed for those new to the field of clinical project management.

Finally, they are offering a virtual course (in May 2023) designed for junior project managers: Clinical Project Management for Small and Medium Sized Pharma Companies

Rutgers University is offering the Certificate in Pharmaceuticals and Clinical Trials Management: This online course is designed to be completed within 12 months, and is specifically designed for candidates from the pharmaceutical and bioscience industries. The course curriculum covers aspects of trial designs, drug development, ethics and statistics relevant to clinical research, and regulatory affairs.

The Pharmaceutical Education and Research Institute, Inc. (PERI)’s Project Management Certificate Program includes a rigorous curriculum in project management, statistical concepts in clinical trials, budgeting and financial management, regulatory affairs, communication and team building, and managing the journey from drug development to commercialization.

Parexel Academy is offering a 2-day seminar in Project Management for Clinical Trials for biopharmaceutical companies to provide their employees with further training in aspects of clinical project management.

They are also offering a five-month course aimed at those interested in starting a career in clinical research, the Virtual Postgraduate Certificate in Clinical Trial Management. The course curriculum covers drug development, regulatory affairs, clinical monitoring, data management, trial management, clinical supplies, professional skills, and industry trends.

The Society of Clinical Research Associates (SOCRA) established the Certification Program for Clinical Research Professionals, designed to standardize the definition and accreditation of clinical research professionals based on considerations of knowledge, education, and experience. The certification is designed to be recognized internationally, and requires candidates to pass an examination, after which they can use the “Certified Clinical Research Professional (CCRP® (SOCRA))” designation. The SOCRA certification exam is offered in-person at facilities in the US and Canada, or computer-based, via Prometric testing centers across the world.

Clinical project manager salary / clinical research manager salary

Clinical project manager salaries can range from approximately $50k to $200k USD per year, depending on the company and the candidate’s education, years of experience, and overall qualifications. According to Glassdoor, the average clinical research manager salary in the US is about $75k USD.

Conclusion

There is increasing demand for clinical research project managers as clinical research and healthcare continue to accelerate and adopt new methodologies and technologies that are opening doors to new types of studies such as decentralized clinical trials (DCTs). Considering the traditionally poor statistics regarding recruitment failures/setbacks and the increasing complexity of protocol design, pharmaceutical companies and CROs will be looking for highly qualified clinical project managers who are up to date with current trends and technologies and have specialized expertise in clinical research project management as prime candidates for helping them overcome these barriers.