Additional resources on our webpages
Our career information page ‘clinical trial management’ includes further links and resources related to this career area.
Career profile: Laura Cortesi, Senior Operational Study Manager
We recently met with Laura Cortesi, who is a Senior Operational Study Manager working in the area of clinical trials management. In addition to talking about her career path, passion and motivation for this career area, Laura explains how parenthood prepared her to work in a role that requires coordination of tight timelines, different needs and unexpected events. She also shares advice for those applying to such roles.
The full interview is below. You also can find out more about the clinical research area in the following resources:
- Article from science careers outlining some of the roles linked to clinical research.
- Overview of clinical research associate role from new scientist careers (a career option related to trial management, more closely linked to clinical trial sites).
- Our previous profile of Barbara Tizzano, Clinical Trial Manager
You’ve worked in various roles in clinical trial management. How did your career progress?
During my “Laurea” (the Italian Master Degree), I worked on basic research in molecular genetics in the oogenesis of Drosophila Melanogaster. I then started to work in the molecular genetic lab in a hospital on the inheritance of cancer, which also involved looking at familiarity risk and genealogical trees. During this time, I had exposure to the clinical trials research at the hospital, collaborating closely with the epidemiologists team and I realized the huge ethical issues posed by this kind of research and the need for international ethics rules and laws when dealing with patients. The ethical questions were huge: mothers who just got diagnosed with breast cancer would immediately ask “what about my daughter”? At that time, there were no clear guidelines on genetic testing of minors and family members. Other open questions included: Is preventative surgery really an option in case of positive testing for genetic predisposition to cancer? This was when I realised that science researchers need to collaborate closely with different professionals, creating multi-functional teams including genetic counsellors, clinical trial specialists, ethicists and more. So, although I loved working in the lab, I decided that clinical trials were an area that I might be passionate about, and I moved hospital to become a study coordinator in oncology.
After a few years, I moved to Heidelberg. At the time, there was not yet a clinical study centre in Heidelberg, and my German would also not be good enough to work in one. I instead found a different type of role within the EMBL campus, at EMBO, where I worked part-time for several years in the web communication team and within the fellowship programmes. Although it was an administrative job, having a science background and understanding the mindset of researchers really helped me succeed in that role and to improve my communications skills in an international environment. I also learnt that it’s really possible to create new projects and find passion in a wide range of roles. Working at EMBL also exposed me to a great multicultural environment – my daughter was for a few years in the EMBL Kinderhaus, which is a ready-made international social life.
I then returned to the clinical trials world, first as a Site Management Associate at a CRO (Clinical Research Organisation), before working at a Pharma company, and then returning to the CRO where I am now Senior Operational Study Manager. I’ve changed jobs and roles several times to find what I like the most: the world of Clinical Operations: the patients and their stories, the site staff, the extended team at CRO and Pharma.
Currently, my teams work mainly on Phase 4 trials – these are conducted when a drug is already approved and available on the market, and it is important to collect “real-world” data. In the earlier studies required for drug approval, there are strict inclusion/exclusion criteria to select which patients can participate hence are exposed to the new drug. After approval, it’s important to see whether there are any unexpected side effects (or adverse events/drug reaction) in certain populations (e.g. with comorbidities, where a patient has more than one disease) or previously undetected safety risks, now showing due to the wider population exposed to the medication.
What helped you progress in your career?
There are multiple things that helped. Firstly, I kept my empathy for the people, starting from the patients: I worked in direct contact with many of them, very sick, while at the hospital and always tried to make them feel cared for. I try to have the same approach for my teams and colleagues– that has always been my personal motivation and I think it makes me successful. I make sure that my teams are comfortable when doing their work and know that if they have any questions they can come to me, and I will support them finding a solution and providing the background information needed to better understand their role and support their professional growth. I try to lead by example: showing I care for them and the patients, and invite them to do the same when interacting with the hospitals and discussing patients’ case or other issues within the study. I also ask my teams for constructive feedback – for example, if I think I came across too pushy I can ask them how I could have approached it differently. It’s important to listen and keep learning.
The world of science is small; the world of clinical research is even smaller. So, what helps your career advancement is a good professional network, and people knowing you are reliable and committed.
Generally speaking, for a career in clinical trials research, it’s important to develop skills like time-management and prioritisation. You need to be structured and come up with plans where the anticipated risks at each step are analysed by multi-functional teams and mitigation strategies are discussed and ready to be implemented. But you need to remain aware that you can’t control everything – sometimes things don’t go according to plans. For example, I once had all the containers with the refrigerated study medication for a clinical trial flooded by the monsoon in Malaysia and no possibility to ship again for days due to weather conditions. You then have to know which is the highest priority and be ready to take immediate action, no matter what was in your calendar and who you have to call in whatever time zone. You need to assess the impact, risks and take decisions quickly to implement a remediation plan asap.
Finally, intercultural communication is extremely important. At the moment, everyone tries to work globally, as even if a compound is approved in one region, other regions might not accept this and the Pharma company would have to restart very expensive clinical trials. In such big international teams, you need to respect each other’s time and each other’s culture. Generally speaking, understanding cross-cultural communications and how to work with a multicultural team can help the teamwork together more productively, but most of all I find it fascinating. Working in an international community means you keep learning and growing also at a personal level. It helps you identify which traits you like to keep of your original culture identity and what you’d like to adopt, to mirror from other cultures as they actually make more sense to you and enrich you.
How did you develop these skills?
For the planning and time-management, I think being a parent was actually the thing that prepared me most – parents have to combine timelines, different needs, unexpected events and inconveniences and still are the adults responsible that all goes well, or as well as possible. As a working parent, you learn very soon that when you have a deadline, your child will certainly get sick, and the more important / bigger the task, the sicker your child will get. Hence you always need a couple of backup plans to make sure someone is available for your child should you not be able to leave your desk at short notice. Sometimes, I had up to plan D! And the other way around: you need to make sure your teams have all the information they need to keep working, even if you have to leave with short notice. And this prepares you later in risk management to be used to have plans in mind even before anything happens.
I also believe being a parent teaches you to lead by example: children don’t learn by listening to what you say, rather they tend to mirror how you behave.
Some people might have the bias that working parents tend to leave work early, and don’t commit too much to their job. But it’s simply not true, or not always. As a parent, it was even more important for me to find my passion beside parenthood, also to inspire my daughter: I’d like her to know that she can find in her life what she is passionate about.
As working parent, I just needed some flexibility in working hours and most of the times this was not an issue. In the field of clinical research, mainly working globally, there’s always a region online – you can work early or late, you just need to get organised. Many of the roles also have some combination of home office, which can help you to better manage your personal life. I personally don’t like working only home office, as I tend to be not disciplined enough to manage my work / life balance and make sure than when I’m supposed to be offline I’m really doing something else, though some of my colleagues really love it.
You mentioned that the patients motivate you – is it hard to maintain that motivation?
Every year we have to do a refresher training. This reminds me every time about the impact Good Clinical Practice (GCP) has had and can have on human lives. There have been a number of horrific cases in the past – from historically poor ethics and lax controls leading to approval of medicines that proved to be unsafe. The example of thalidomide, a drug for which the teratogenic risk was initially not clear, is one famous and sad example. It was available over the counter for the treatment of morning sickness during pregnancy and seemed a great remedy. Only after a few years, it became clear it actually causes teratogenic deformities in children exposed during intra-uterine life. By that time,
it had affected tens of thousands of children. This really shows the importance of well managed clinical trials, studies and reviews of the safety signal and how the work we do has an impact on people’s life, also for the patients of the future.
What’s important for PhDs to know, if they are thinking of a career in clinical trials?
The first thing to acknowledge is that it is a different field, and a highly regulated and complex one. I believe all parts of scientific research are needed to increase our understanding of how our nature and our body works, what’s behind the onset of a disease and how it can be treated and sometimes cured. Each and every professional can give his/her contribution to bring a medication from the wet-lab to the patient, and each role is important as well as having its challenges and professional satisfactions.
Scientists who come with the mindset that they want to learn how this works, will be successful. Those that expect a simpler job compared to the lab one, or feel they are doing just an admin job, sink most of the time and do not succeed: it looks like a completely different world, but it’s one that still requires passion, commitment, eagerness to learn and to develop. People need to make this switch with enthusiasm and an open mind. You start from zero, from an entry level, even if you were coordinating a team in the lab – but you can find the same passion with time and you will be investing in a new career with lots of opportunities.
The company you join will train you, give you mentors who you can talk to (and I always recommend to do so as much as possible). Nevertheless, the amount of information at the beginning is overwhelming even for great PhDs or Postdocs new to the field. The Regulatory Authorities like the FDA, the EMA (i.e. the authorities to whom clinical trial data are submitted for medicine approvals) have an infinite amount of guidelines for study trial conduct. Therefore, each company has hundreds of standard operating procedures and work instructions, where each single word and nuances have a specific meaning. A person coming from a PhD is highly appreciated because they have a mind trained to study, but s/he needs to be willing to do so very seriously.
Additionally, everything must be documented in a specific way, in specific systems. At any moment there could be an announced or unannounced audit or inspection (e.g. from a Regulatory Authority), and everything has to be shown and documented to prove the validity of the data submitted for approval and the processes followed while conducting the study. Ideally, we have to work inspection ready. For this reason, you need to understand not only the priorities, but also how to document anything that has happened in a clear, timely and compliant way. It is often stated that if it is not documented it did not happen – even phone calls have to be documented: who stated what, when; risks and open follow-up items or next actions. This is where the mindset is different. This is not scary, it can be friendly as it involves collaborating with big international teams, still it has to follow defined standards, always.
For those thinking of applying, I recommend to invest time wisely while doing job hunting, exploring the best strategy to enter the role. It is worth spending time on networks like LinkedIn to see if there is a common connection, or approach people directly, so you can ask what the expectations are for working in a certain position, and what the job description actually means (which are sometimes not easy to understand especially from the outside). Also contacting head hunters might be an option.
When we have a good candidate for whom we can do a referral to our employer, our company is often more likely to contact this person, as we’ve already told said person what to expect and should have a preliminary understanding of the job requirements; besides, s/he has shown a real interest. Networking is a better time investment that sending the same CV to lots of roles. I heard many people, some with a high-graded PhD and postdoc from the best universities, saying that they sent hundreds of applications and didn’t get a single reply before they learnt how to submit a job application properly.
On the cover page, potential employers need to see your understanding that it’s a new world to which you are excited to enter, you have an understanding of the role/company and you are committed and dedicated to what you do, you did, you would like to have the opportunity to do. Having a friend or contact from your network reviewing your cover letter is also a good idea.
If you get an interview, the message shouldn’t be “I’ll do anything” – no one needs an amoeba! and it is often seen to reflect a rather limited interest in what you do and in your career. You need to have and to show an interest in the role, in the company and a willingness to develop: say what you understand about the position, and what questions you have (always prepare some questions); and don’t be afraid to talk about the challenges you faced in your PhD and how you overcame these. These can really prove your true colours (in a positive way), just don’t keep it too long: you are applying for a career change after all.
There’s also a wrong assumption that in some companies you need to be aggressive. In my opinion, that’s incorrect: it is more valued if you can show you are a good team player. You need to show that (and hopefully it’s true that you are!).
EMBL fellows and staff members can contact Laura – and other former staff/fellows working in clinical trials and other non-academic roles – via the EMBL Alumni Directory. Please see our article on informational interviews for ideas on how to make the most of such opportunities.
