We would like to get you all acquainted with our Clinical Project Manager. An interview where we talk about her expertise, how a normal workday looks like and which trends she observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
Let's start with a small introduction, could you tell me something about yourself?
My name is Rachel Derksen. My background is Biomedical Chemistry, with clinical chemistry as specialty. I started working as a CPM in 1998 for a very small Dutch pacemaker company called Vitratron. After two years we were taken over by Medtronic where I continued in my role as Global CPM. After 10 years being with this company, and being a mother of three children, I decided to work as a freelancer. The flexibility in this role enabled me to combine my work and personal life.
As a clinical project manager, I am responsible for the design, execution and completion of a clinical study. A study that has to comply to the international guidelines of the ISO14155 GCP, fits within budgets and their time schedules. Execution of a study requires team-efforts from all disciplines within clinical investigation and I believe that only together we can make a study successful.
As freelancer, I have fulfilled many different roles in both the pharmaceutical industry as well as the medical device industry, in all kinds of areas, and different phases of a clinical trial both at the office and in the field.
Which part of your job do you prefer the most?
What I like about my job is to be part of the big picture in which people or companies strive for a better quality of life for human kind. The idea behind some products is sometimes so fascinating that I occasionally wonder where the limit is. This dynamic environment makes it interesting and valuable for me to be part of it, and of course the synergy required among all stakeholders to make it successful.
What does a normal workday looks like as a consultant?
Well, first of all, I start my day with a long walk with my two dogs in the wood in order to clear my mind. With this empty mind, I open my inbox and see what is planned for that day or week. This could be a day at the office, having meetings with team-members, or writing plans and/or reports, or this could be a day in the field, talking with clients how to set-up their clinical investigation, or talking to investigators on how to implement the clinical investigation at their site. Besides that, I also provide several trainings to help other people or companies with their clinical investigation knowledge.
What kind of studies are you doing at the moment or have you done in the past?
At the moment, I am working on a study in the urology section where we are testing a cystoscope. In addition, I am expecting to do studies where we are going to test smartwatches.
In the past, I have done studies regarding artificial heart transplant, artificial pancreatic transplants. But also studies centered around stents, pacemakers, IVDs and other medical devices.
How are you dealing with hospitals and limited capacities at the moment?
We try to help by doing as much preparation-work as we can. However, we try to prevent limited capacity during the site selection visit in the first place. The site selection visit is a visit where we communicate our expectations towards the researcher and her/his team. Discussing resources is part of this. If resources are limited, we can decide to not participate this study.
Now, with the limited capacities due to COVID, we sometimes can not continue a study. We will balance out the risks patients might run in to, to the situation we are in because of COVID. When we expect hardly any risks, we decide to pause the study unless we can monitor it remotely.
Which trends have you spotted at the moment?
The new MDR guidelines, and therefore the new ISO14155.
How do you stay up to date with everything that is happening in the MedTech-world?
I am linked via LinkedIn and read relevant articles there. Due to a large network a lot of important information is shared or even discussed via this media. Also, in my previous role, I visited many companies, and each company has his own expertise. This helped me to stay up to date in the MedTech world.
What is your advice for our customers?
Begin with the end in mind, use common sense and take sufficient preparation time!
Would you like to know more about Rachel? Click here for her full profile.