How to start a career as a Clinical Trial Project Manager
Published: 05.17.2023
Project managers of a contract research organization (CRO) plan and organize clinical trials and various studies in a leading role. What qualities do they need to have, and what is the best way to enter the profession?
What are the tasks of a project manager in clinical trials?
Clinical project managers are mainly responsible for the overall planning, organization, and monitoring of studies, scientific projects and clinical trials. They coordinate the cooperation of all departments in order to successfully carry out a clinical trial or non-interventional study. They coordinate all departments to ensure a smooth and successful trial process while adhering to timelines, quality standards, and budgets. Additionally, they serve as key points of contact for all stakeholders, including sponsors, regulatory authorities, trial centers, and clinical monitors.
What education is suitable for project managers?
There is no one path to clinical research. A look at the staff at Alcedis makes this clear: The teams consist of chemists, biochemists, biologists, ecotrophologists, business scientists or medical documentalists, among others. These different specifications reflect the different areas of responsibility in the organization of clinical trials. Here, a multidisciplinary team works together and takes into account medical aspects as well as laws and logistics.
For those who want to prepare specifically for a career in clinical trial project management, universities in Berlin, Hamburg or Leipzig offer specialized courses such as Clinical Research or Clinical Trial Management. In addition, interested parties can attend intensive courses on planning and conducting studies at institutions such as the mibeg Institute for Medicine in Cologne or various pharmaceutical academies throughout Germany.
Latest White Paper
How do you start your career in clinical research?
Many young professionals and career changers take their first steps in clinical research as clinical monitors or clinical research associates (CRA). Among other things, CRAs monitor compliance with current regulations - such as Good Clinical Practice (GCP) - and the trial protocol in clinics and medical practices that serve as trial centers. They accompany the study centers throughout the entire study conduct. Whether employed or self-employed - due to the varied day-to-day work and the opportunities for further development, the profession of a CRA is very attractive for many. Above all, the tasks of a CRA offer insights into both a contract research organization (CRO) and the study implementation in the study centers on site.
Some, on the other hand, enter clinical research as project assistants, study coordinators or junior project managers after their studies, doctorate or postdoc phase. Usually, they then work together with experienced project managers. In the first few months in this profession, numerous on-the-job training courses enable them to quickly familiarize themselves with the work processes. In addition, strong mentoring is important so that newcomers gain a comprehensive overview of the various aspects of clinical research and the responsibilities of the teams. A structured induction and continuous support in the first few months are crucial to efficiently understand and successfully implement the processes and services in clinical research.
Do applicants in clinical project management need medical knowledge?
While previous medical knowledge is very helpful, it is not always mandatory. However, applicants should have a strong interest in medicine, life sciences and research. After all, in clinical trials, register studies or even non-interventional studies, various medical aspects have to be taken into account, depending on the disease to be investigated. Which values should be measured? And with which devices? What is the effect of the investigational drug or study drug to be examined? How is the medical product used? What symptoms are common, and what side effects occur with the investigational drug?
Working on clinical trials therefore involves constant self-study and continuing education. This also applies to the many regulations that have to be observed. Looking up laws, guidelines or regulations, for example, from the European Commission or the authorities, is part of everyday life. For beginners, it is worth taking a look at Good Clinical Practice (e.g. ICH E61 or ISO2) or the Declaration of Helsinki3. These documents serve as regulations for the conduct of studies and trials.
What qualities are needed for the organization of clinical trials?
Above all, applicants should have the following:
- Organizational skills
- Problem-solving ability
- Confidence in communication
- Passion for medical issues
- Interest in innovation
- Adaptability
Organizing and planning a clinical trial or a study requires a structured way of working. Those responsible must always keep track of finances or deadlines. Diligence and thoroughness count, strict regulations and internationally applicable guidelines must be adhered to. Failure to do so - for example, if documents are not submitted completely or on time - will lead to delays or fines.
Regular consultations with the team are crucial for the success of a trial. After all, project leaders are considered the contact person for all parties involved, be it for sponsors of the clinical trial, trial centers or clinical monitors.
Another important point is to be enthusiastic about innovations. Clinical research is constantly evolving: New technologies such as the integration of smartphones and smartwatches as well as the acceleration of work processes through artificial intelligence are just a few examples of the increasing influence of digitalization in clinical research and enable more efficient services in study design.
Project managers are also characterized by fast, spontaneous action and strategic rethinking. After all, clinical trials and studies are subject to the influence of a wide variety of conditions. Problems can arise every day that nobody expects: Patients unexpectedly drop out of a trial or a storm delays the delivery of investigational medicinal products. The coronavirus pandemic has also had an impact on daily work in recent years. Strategic project management is therefore essential in order to ensure that the trial runs smoothly even in challenging situations.
"Project managers have to be diplomatic, stress-resistant and pragmatic. Creative outside-the-box thinkers, always looking for a good compromise between quality, timelines and budget, while keeping an eye on the big picture to ideally fulfil their role." - Jan Müller-Thompson (Clinical Project Manager at Alcedis).
1ICH harmonised guideline integrated addendum to ICH E6(R1): Leitlinie Zur Guten Klinischen Praxis