Meet Elzbieta Lech, our Poland-based Senior Clinical Project Manager
ExperTrials prides itself on its international team of clinical research experts. On our blog, you already had the chance to read about Aurélie Weiss-Guimet, our Contract Research Organization CEO and Founder, Christoph Wachter, Head of Clinical Operations, and Ghazala Kabani, our new Head of Clinical Operations in the United States. Elzbieta Lech, our latest Senior Clinical Project Manager, is based in Poland. She is fond of clinical regulations as much as project management. Read all about it in the interview below.
Before joining the clinical research industry, you spent several years practicing medicine. Can you tell us more about the early days of your professional career?
As a 6-year old child, I already took care of the twin babies that lived next-door. I can’t believe how responsible I was back then! I originally wanted to be a “children’s doctor”, and more specifically a pediatrician and neonatologist. At that time, that specialization was closed so I decided to go into the anesthesiology and intensive care unit. I could take care of new born babies there and that made me quite happy.
Between the late 1990s and early 2000s, I spent seven years working in a 3rd reference Warsaw hospital: those are the highly specialized hospitals in Poland. The work was very hard and the pay very low. I was young and the first to be chosen for the night duties. It was hard on my family and personal life. I loved my work there, but am happy I switched to clinical research.
How did you make the transition from being a physician to becoming a Clinical Research professional?
A lot of my friends moved to that industry. At the time, I organized a lot of trainings for the anesthesiologists and realized I was good at administrative work and enjoyed it as well. I found out clinical research could be a relevant career choice for me. I was recommended by one of my colleagues and started working as a Clinical Research Assistant. I soon became a Clinical Research Associate.
As the years went by, I managed to move to a Senior Clinical Research Associate position. I was involved in regulatory work locally as well as in monitoring. I became a Regulatory Lead and then a Manager in smaller CROs in addition to being a Senior CRA. When the two activities were divided, I became a Regulatory Services Project Manager in a mid-size CRO.
What is it that you like so much about regulatory work?
It is challenging work and it is never boring: everything changes constantly. The start-up phase has to be watched very closely, but it also finishes at some point: I get a sense of accomplishment from seeing its quick delivery. I also like the legal part of it. I love negotiating contracts.
I adapt very well to changing environments, be they the clients, the projects, or the standard operating procedures.
Since 2011, when I became a Regulatory Project Manager, I have been involved in global studies, mainly in Europe and the United States, and also in Asia-Pacific and Latin America.
You have also become an expert in project management. How do you feel about it?
I have been doing project management since 2008: I started working for small biotech clients that needed one person to see their projects through. I enjoy the collaboration with small sponsors: I like to be the person influencing all the decisions. I focus on quality and set high standards for the work I do. I check everything that is done so as to avoid errors: it saves time eventually.
Every CRO I work for appreciates the high-quality work I do, even though it might take a bit longer than expected.
As a project manager, you are the first contact point with the client. It has an impact on the work relationship you build with them. I consider every project as my baby. I am very organized so as to be able to follow every project as closely as possible and keep priorities in mind. As a manager, I also make sure that people like to work for and with me.
You have been working as Senior Clinical Project Manager for ExperTrials for a year. When and how did you become a freelance consultant?
I became a freelance consultant in 2018 because I like to be independent and have job flexibility. I started working for ExperTrials in 2023. Aurélie found me on LinkedIn last year. We clicked immediately: we share work values and enjoy building a warm working relationship.
In small trials, it is reasonable and cost- and time-effective to have one project manager and not two managers (clinical and regulatory). The fact that I have experience in project management and expertise in regulatory submissions is quite helpful. I also have expertise in advanced therapy and medical device studies. I am continuously learning about clinical research and broadening my knowledge.