As a Director within the Clinical Research Group, Coralie provides leadership and supervision to internal and external cross-functional teams. She is responsible for the coordination and oversight of all activities related to the planning, conduct and completion of clinical trials in compliance with corporate and client SOPs, ICH/GCP and local regulatory requirements, to ensure the trial is completed within the agreed budget and timelines.
This includes the development, review, and approval of all study-related documents for submission to Competent Authorities and Ethics Committees, together with approval of the selection of clinical trial sites, overseeing monitoring and investigational product supply, data management and biostatistics, the selection and management of CROs and vendors, the management of clinical trial budgets and the provision of study status updates.
Coralie has experience of conducting trials in both adult and pediatric populations, across a wide variety of common and rare diseases (e.g., atypical hemolytic uremic syndrome, nephrology, and hypophosphatasia, metabolic disorder).
She brings to the role 16 years of experience in the management of all phases of international clinical studies and has developed effective working relationship with internal and external partners in North America, Europe, Russia, Middle East, Australia and Asia (including Japan).
Prior to joining VCLS, Coralie held several positions in the clinical trials arena: Scientific Associate at the Ethics Committee Vaud (Switzerland), Senior Clinical Project Lead at Alexion Pharma International (Switzerland), and Clinical Study Manager at Institut de Recherches Internationales Servier (France).
Coralie earned her Pharm.D at University of Angers, College of Pharmacy, and a M.Sc in Quality and Logistics Management in Healthcare Companies.