How to start a career as a Clinical Trial Project Manager
Project managers of a contract research organisation (CRO) plan and organise 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?
Project managers are mainly responsible for the planning and organisation 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. In doing so, they ensure that schedules and deadlines, quality standards and budgets are adhered to. This also means that they are always available to answer questions for all those involved.
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 organisation of clinical trials. Here, a multidisciplinary team works together and takes into account medical aspects as well as laws and logistics.
There are also offers for those who focus on working in clinical research as a career goal from the very beginning. Universities, among others in Berlin, Hamburg or Leipzig, now offer 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.
How do you start your carrer in clinical research?
Many career 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 practices that serve as study centres. They accompany the study centres throughout the entire study conduct. Whether employed or self-employed - due to the varied daily 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 organisation (CRO) and the study implementation in the study centres 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 their first few months in this job, numerous on-the-job trainings help them get started quickly. Strong mentoring is important so that newcomers get an overview of the different aspects of clinical research and the responsibilities of the teams.
Do applicants need medical knowledge?
Previous medical knowledge is very helpful, but not always mandatory. 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 organisation of clinical trials?
Above all, applicants should have the following:
- Organisational skills
- Problem-solving ability
- Confidence in communication
- Passion for medical issues
- Interest in innovation
- Adaptability
Organising 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 centres 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 digitalisation has on clinical research.
Fast, spontaneous action and strategic rethinking also characterise project managers. This is because clinical trials and studies are subject to the influence of a wide variety of conditions. Problems can arise every day that no one expects: Patients unexpectedly drop out of the study or a storm delays the delivery of the investigational medicinal products. The Corona pandemic also influenced daily work in recent years. The challenge for project managers then is to find solutions to these problems.
"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
Text: Alcedis-Redaktion