They plan and organise clinical trials in a leading role: In this interview, four project managers from Alcedis talk about their entry into the pharmaceutical industry and their careers.
Who are you?
Johannes, 32, with Alcedis for one and a half years, responsible for three non-interventional studies in ophthalmology, nephropathy and oncology.
Katharina, 28, with Alcedis for two and a half years, is currently working on five non-interventional and two medical device studies with different indications.
Hendrik, 35, with Alcedis for one and a half years, responsible for the HANSE study on early lung cancer detection in Germany, among other things.
Alexandra, 39, with Alcedis for eleven years, leads several phase I-IV studies in dermatological oncology.
How did you get into clinical research?
I studied sports science in Mainz and biomechanics-motor movement analysis in Giessen. Afterwards I worked at the university and did my doctorate. I enjoyed that a lot. Because I wanted to continue working in the scientific field, I saw great professional potential for me in clinical research.
I have always been interested in the subject of health, which is why I chose to study nutritional sciences. Besides my studies, I worked as a research assistant and examined patients in studies for supplements, among other things. So I first got to know clinical studies from the side of the study team on site and the patients. My best friend told me about his work at Alcedis, so I applied directly towards the end of my studies.
I completed my degree in biology in Giessen with a focus on molecular biology and then went on to do my doctorate. Accompanying and shaping a project in research for years was very appealing to me and gave me great pleasure. Nevertheless, the university structures were too uncertain for me and I wanted to try something new. It was clear to me that I wanted to leave the university after my doctorate and make the switch to industry.
How did you prepare for the work in clinical research?
In preparation, I read various books about clinical trials and researched the pharmaceutical world on the internet, especially about the fields of work at Alcedis.
Before joining Alcedis, I completed a training course that lasted several months. The course, called Life Sciences Management, included various modules on quality management, project management and pharmaceutical economics. In case studies, we had to draw up project plans or organise Corona vaccine deliveries to Europe. This not only gave me first insights, but also certificates that were very helpful for my application at Alcedis.
Apart from the experience you gain during your studies or doctorate, I started my employment feeling quite unprepared. I originally planned to take an intensive course at the mibeg Institute of Medicine, but at Alcedis I managed a direct lateral entry as a clinical monitor before that. I learned a few basics through books and the internet.
How did the first months go?
I already suspected - and this also became clear during my interview with the head of department - that many things would be new to me. That's why I spent the first six months reading up on the regulations and laws. I took over my first project from a colleague who changed departments and trained me well.
In the beginning, I received a lot of training on the different work processes. But I learned best in practice, by directly applying what I had learned in my everyday work. My head of department and my mentor introduced me to my tasks and discussed them with me in detail.
Some tasks were similar to my work at university. Sponsor meetings, for example, are like scientific lectures, so I was familiar with discussing the current points and next steps of a project in front of an expert audience - these appointments were easy for me. Other tasks, such as contract management or budget planning, were organised differently at the university and were correspondingly more difficult for me. I was lucky to have competent and friendly colleagues whom I could ask for help at any time.
For me, the start was a classic "training on the job". I was fresh out of university and knew very little about clinical trials. In the beginning, I travelled a lot as a clinical monitor and got to know how clinical trials are conducted on site. This was followed by a smooth transition to project management. When I started at Alcedis eleven years ago, the company was still smaller, I didn't really have a mentor or anything like that, and so I had to take on my own projects and thus a lot of responsibility quite early on. Today, the induction is structured differently. "Old hands" like me introduce the young project managers to the work processes. This is an important step because regulations, such as data protection, are more complex and the demands are higher than before.
What have you learned about clinical research that no one can prepare for?
You have to learn to think yourself into the sponsor and the project. That comes with time and was "learning by doing" for me.
I didn't expect the job to be so varied. Every day I encountered a new task or challenge. A phone call or an email can change the whole day. It is important to keep tasks and deadlines in mind, but at the same time you should stay flexible in your daily life and set priorities.
Every study has its own challenges that no one can prepare you for. You should approach the small - and sometimes larger - problems with a certain amount of composure. Especially since you can count on the support of your colleagues. However, this feeling of serenity only came to me with a certain amount of professional and life experience.
What advicece would you give to your younger self?
Have the courage to just ask. If you're stuck on a task, it's always better to ask for help, it's the quickest way to solve the problem. Colleagues are always happy to help.
You should always ask "why". One of my colleagues always says: "If you know the why, you can approach the tasks completely differently." Also, I would have liked to realise earlier that my colleagues all once faced the same challenges as me. That made it easier for me to turn to them when I had questions.
I studied medical technology before because I would have had good career prospects as an engineer. But in the end I wanted to study something I really wanted to do. That's how I came to study biology and clinical research later on. That's why I would recommend to my younger self to think carefully about your choice of studies. You can only achieve good results if you enjoy a task and are fully motivated.
In retrospect, I thought: If I had had the opportunity to do an intensive seminar followed by one or more internships, for example in clinical monitoring or data management, I would certainly have had an easier start. In addition, it would have helped me to orientate myself better in my professional field and to set priorities in my tasks.