Bakken Research Center
Born and raised in Heerlen, 500 meters from the Medtronic office, it wasn’t a tough decision where Sandra wanted to work: at Medtronic!
She started in 2002 as an Associate Clinical Study Manager at the Cardiac Surgery department.
I am a Senior Manager responsible for Clinical Quality and Clinical Customer Services for the Coronary and Structural Heart (CSH) department. With my global team
(four employees in the US and one in Canada), we are supporting study teams to ensure our 60+ global studies are compliant with current regulations and are audit/inspection ready. We are also making sure that investigators receive the required non-commercial products to treat the patients in the studies conducted at their sites.
I started in 2002 as an Associate Clinical Study Manager in Cardiac Surgery. At that time, there were hardly any regulations and running a study was relatively easy. Over time, I not only grew to a senior level in my role, but the regulations became more stringent as well. In 2008, I joined the Clinical Quality department. I audited studies to check if they were being performed in compliance with the applicable regulations, and I supported companies acquired by Medtronic, in transferring their ongoing studies to our internal clinical quality system.
Since 2011, I lead the Engager clinical program, one of the transcatheter aortic heart valves which the Structural Heart business acquired. Leading a team of five, we generated all clinical data that led to commercialization of the valve. Unfortunately, due to suboptimal performance, we also had to phase out this same valve and shut down the clinical studies.
In 2014, I moved to the (global) Project Management Office team as a program manager. Instead of actively managing studies, I ensured that all studies managed from the Maastricht office were performed within scope, schedule and budget and that all applicable study data were available for internal reporting. In addition, I set up several global processes to track resources and costs. I was also trained to become an inspection coordinator. Since 2018, I have global responsibility for CSH Clinical Quality.
My main challenge is to find the right balance between supporting study teams to perform a highly compliant study without jeopardizing time to market, so that we can serve our patients.
Due to my global role, I have the opportunity to work with teams around the world. On
one day, I can be working with a Japanese team in the morning and a US team in the late afternoon. It is fascinating to see how different cultures result in different solutions for the same problem.
What I like most about Medtronic, is that the work never gets boring. I have had the opportunity to work in many different roles which kept me on my toes. I am constantly challenged to learn new things. And with big changes in the medical device regulations in Europe coming up in 2020, this will certainly not stop in the following years.
I am contributing to the Medtronic Mission by supporting high-quality studies of which the data is used to bring new products to the market. Within CSH, we run a transcatheter valve replacement program for the mitral valve. Since no transcatheter mitral valve is available on the market yet (also not from our competitors), it will be a big step forward if our studies could help to bring that therapy to the market and help treat patients that now have limited treatment options left.
‘Further, Together’ to me signifies that we need to work together to advance our therapies and serve our patients. Within the current complex regulatory environment, there is no room for egos, only for team players.
I was overwhelmed with joy when the Engager valve received the CE mark. As a team, we collaborated strongly and used the time zone differences in our advantage during the last months of the project to speed up the time to market. The team exploded with happiness when the message finally came that the product was approved.