For over 12 years I ran European Clinical Research activities for WL Gore & Associates, a Global MedDev company.
Mid 2016 I took the decision to leave W.L Gore to better reconcile my inner self with a meaningful and lasting professional objective and challenge myself into a fresh and new path.
I repurposed my career into consulting, focusing my expertise on EU Clinical Research support.
For over 12 years I ran European Clinical Research activities at different level for WL Gore & Associates, a Global MedDev company.
Part of an international, cosmopolitan and highly professional clinical team, I led, designed, planned, implemented and managed international Clinical Research projects involving new, innovative and high technology oriented products in the medical device area.
My main accountabilities focused on CE marked/Post marketing studies Endovascular Specialist, more particularly Aortic segment through a cross functional and multi BU approach where I was the KOL key primary contact.
I fully managed different Clinical Research projects in accordance with approved procedures (extensive knowledge of ICH GCP) and Standard Operating Procedures (SOPs) as well as other EU local regulation to provide high quality data in full compliance with subject safety. I led and managed both EU and local EC/CA processes, providing and maintaining a strong dimension of clinical expertise and knowledge within business needs and tight timelines.
I led vendors, interfaced as well as managed cross-functional operation with other internal departments to ensure efficient coordination of clinical activities.
