During a recent visit to EMBL Hamburg, we met EMBL alumna Barbara Tizzano, who shared her experience of moving into clinical trial management. This is a career area that may be attractive for people who love coordinating projects and bringing people together to solve real-life problems.
The full interview is below. You also can find out more about the clinical research area in the following resources:
What is your role as a clinical trial manager?
I do management of clinical trials which means, organising and providing support to clinical trials from the planning phase until the final data report. This starts with submission to ethics committees and local authorities, proceeds with the actual clinical trial phase — here we follow all the procedures related to patients’ recruitment, the monitoring during the trial and all the steps until the last patient has completed the last visit to make sure the patients’ rights and safety, as well as international legal requirements, are respected.
You are organizing clinical trials worldwide – working on multiple projects at different stages – what does your day look like and who do you interact with in the company?
There are lots of meetings and telephone conferences. In one project there could be the sponsor in America, and the clinical trial might be happening in Europe; and the drug or the medical product might be produced in Australia.
Clinical trial management means working closely with other teams, for example the data management and statistical team who will deal with the trial data, or the medical writer who will write up the report.
And in what ways is this similar to the work you are doing in academia and in what ways different?
There is basic science behind each product or drug to be tested, there are of course previous pre-clinical studies – in mice or other animals, producing data and scientific publications. When you read the protocol for a new clinical trial you have all this – if you go into the publications you get into the meaning of the study. Otherwise it’s pretty much different, there is no bench and nothing to pipette!
Do you then still feel that you are using your training?
A scientific background definitely helps understanding the rationale behind a trial. Then, exactly like with scientific projects, you are dealing with many different things. You have to deal with administration, safety aspects, budget and actual testing of the product. The communication skills that a researcher has to learn to present his/her science, the coordination skills you need for your own research project and making this work, these are all important prerequisites to manage clinical trials too. Managing an international trial it’s like having collaborations and working on a paper with different labs all over the world, dealing with many different pieces and putting them together.
Are then communication and organization the most important skills, or are there other things that are important?
Being able to read and understand not only scientific topics, but laws and agreements. You have to read in a critical way and always be up to date with national and international guidelines and their amendments. You are the link between the local authorities, deciding on the feasibility of a trial, and the sponsor, investing in it.
What is the best part?
What I enjoy the most is really this coordination: to have the opportunity to coordinate many people across the world to make the trial work. I like collaborating with teams located on the other side of the world and think that, despite time differences, cultural differences and distances we all work for a common goal. A bit like it happens in challenging scientific projects.
What’s the main intellectual challenge in the role?
You have to combine many different things – so you are definitely using your brain, sometimes even too much. There are so many aspects you need to take into account including the ethical aspects. A strong scientific background–the knowledge on how a particular family of drugs works or knowledge of a certain disease might actually help offering the best advice during the delicate planning phase of a new clinical trial. So reading and updating yourself on whatever concerns the trial field is not only interesting but also an advantage for the trial itself. It’s definitely not boring and can be quite demanding.
How did you make the transition?
After EMBL, I did four and a half years microbiology at a leading institute for tuberculosis research. I was doing basic research, but there was a hospital linked to the institute and some of the doctors were doing clinical trials. I came into contact with these doctors through seminars and discussions, and realized how useful the research can be when it comes to patients and an actual disease. Then I got interested in human research and clinical trials, and I said: “okay – let’s do something different”. That isn’t easy, as when you’ve been doing basic research, you don’t have the basic knowledge of what clinical research is, also in terms of legislation. So I did a course that was a few months long and really intensive. It was designed for people with a scientific or medical background who would like to be a clinical research associate (although that’s not the role I have now). I then started to apply to all possible pharma companies and CROs, and it actually went pretty fast. I had an interview with a CRO and although I didn’t have yet the expertise they were asking for, they positively rated my scientific background, my motivation and my willingness to catch up quickly the necessary expertises. I’ve been there 2-years now. I started as an assistant, and it went pretty fast to manager.
Is there any advice you’d give to people interested in this area, to make them more attractive to employers.
I think what is really important, more than the experience – I had none whatsoever – is the willingness to play in a team. This doesn’t always happen in science, where you are often concentrated on your own project and your own experiments. In clinical trial management, you always have to work in a team. The motivation is also really important – it is really the first thing hiring managers look for. They also look for people who are “good mood people” – you have to face and solve lots of problems, having a positive attitude helps you finding solutions and incentivises you colleagues to do the same. So I’d say problem-solving, communication and the ability to be and bring people to be positive are important skills to work on and communicate in your job applications.
I would also really advise taking one of the courses offering training for this career area, there are really many of them, and I am not sure they would have considered my CV without it. It’s good to do it in the country you plan to work in so that it is recognised.
Your working language is German. Did you have to work on your German to get the position?
The course I did was already in German and doing this course was a big challenge – it was made for Germans, not foreigners. So after doing a course for 4 -5 months from the morning to the evening and then the exams in German, my German became pretty good. Now it is improving every day. I am just using English with the sponsors and in teleconferences.
Working in a foreign language is not easy, but never underestimate how important it might be for a company to have a multilingual staff!
How would you say the work-life balance is in comparison to academia?
I think there are more options. In my company, the majority of people are women with children. They can choose to work from home or to work fewer hours -for example, you could do 2 full days in the office and the other days part-time at home, or work full time. So it’s really flexible – at least in my company. I would say this really helps those who have family.
Is there anything we didn’t cover, that you think you would have liked to have known when you were starting to think about this career area as a postdoc?
You will miss the lab sooner or later, and it is normal – science has been and will always stay part of your life. But if you work in a nice environment with people who understand you and you feel good with, it will work. Environment is really important – when looking for a company, I’d suggest to really look at the company and get a feeling for the people. If you did science and enjoyed it, it gave you more than you would imagine. If you decide it is time to move to something else, do it, it is most probably the right choice at the right moment.
Barbara can be contacted by email at email@example.com. EMBL staff/alumni can contact Barbara via the EMBL Alumni Directory and receive details of Barbara’s LinkedIn account from firstname.lastname@example.org.
EMBL staff / fellows can also search and contact other EMBL Alumni working in clinical research – or other career areas – to seek career advice / informal mentoring via the EMBL Alumni Directory. Please see our article on informational interviews for ideas on how to make the most of such opportunities.