Vincent Willems Email & Phone Number

Leuven, Flanders, Be

Brussels, Brussels Region, Belgium

Brussel En Omgeving, België

Brussels Area, Belgium

Brussels Area, Belgium

o Overall project management of assigned trials; coordination of all activities to complete essential study deliverables, study-specific operating guides and trial master files until the finalization of the Clinical Study Report.o Provide assistance in all phases of the clinical trial from planning stages and regulatory submission to patient recruitment and data collection, always ensuring protection and well-being of research participants and the integrity of research results.o Generate Medical Affairs related initiatives to support commercial activities, accelerate enrollment and increase study value.o Ensure adequate contribution, results and accountability when managing core labs and CROs to ensure adherence to relevant SOPs, GCP and regulatory requirements.o Share knowledge and lead regular debriefing inside and outside of the clinical team (including R&D and Sales & Marketing group).

o Continuation of the role at Medrad, after integration into Bayer HeatlhCare. o Educational, clinical & technical support to clinical sites involved in the clinical study program (on-site and off-site);o Support execution of global clinical strategy at assigned clinical sites including lead site recruitment, site support, patient enrollment and site implementation of study protocols;o Assist with successful conduct of assigned studies consistent with research, clinical, development and marketing plans;o Provide input into the preparation and review of Investigational Plans, other study materials and training materials of investigators and site staff;o Oversee and assist study monitors at participating centers to ensure compliance with protocol and regulations;o Provide input to Research and Development as well as Marketing regarding product enhancements or new product development ideas;

o Educational, clinical & technical support to clinical sites involved in the clinical study program (on-site and off-site);o Support execution of global clinical strategy at assigned clinical sites including lead site recruitment, site support, patient enrollment and site implementation of study protocols;o Assist with successful conduct of assigned studies consistent with research, clinical, development and marketing plans;o Provide input into the preparation and review of Investigational Plans, other study materials and training materials of investigators and site staff;o Oversee and assist study monitors at participating centers to ensure compliance with protocol and regulations;o Provide input to Research and Development as well as Marketing regarding product enhancements or new product development ideas;

o Development, design and execution of clinical trials;o Close collaboration with medical field professionals;o Planning and coordination of various project activities to ensure timely completion of the trial;o Internal & external reporting on progress and results of clinical projects; o Ensuring compliance with regulatory directives / guidelines and the Clinical Investigation Plan;o Planning and organization of internal and external clinical trial training and meetings;

o Collection and on-site validation of clinical and technical data;o Preparation and participation to study initiation meetings (internal and external);o Frequent travel to investigational sites (EMEAC region);o Participation to clinical trial development and document review process;o Administrative support of all project related activities to ensure timely completion of the clinical trial;

G.A.S., Biomedical & Clinical Engineering

Dissertation: “Analysis and classification of atrial fibrillation” K.U.Leuven, 2002-2003

Ing., Electro-Mechanical Engineering

“Design and construction of an educational tool explaining the functioning of the electronic fuel injection system (PGM-FI).

Education record