Clinical Trial Manager
Desirée Kanters is responsible for the clinical operations activities of Phase I & II clinical studies (set-up, execution, closing, reporting, vendor selection, vendor oversight, budget and time management). She has more than 20 years of experience in clinical development in multiple therapeutic areas such as oncology, respiratory diseases, cardiovascular, metabolic diseases, hypertension, CNS, infectious diseases, inflammation, gastro-enterology, urology, vaccination and orphan diseases. She gathered her experience at big pharma, biotech and CRO companies including Galapagos, Astellas, Movetis, 2Bridge, PRA, Icon and many more. Her responsibilities ranged from the valuation of quality and integrity of an investigational study site or CRO/vendor related to the proper conduct of the study and adherence to applicable regulations, to providing input to IND submission dossier, IB, scientific advice, protocol, briefing document, ICF, eCRF, regulatory files, and reviewing clinical study protocols, clinical study reports, statistical analysis plans, mock tables, listings and figures, DSMB charters. She ensures consistency across in the operational set-up, conduct and closure of all clinical studies by coordinating and planning multiple projects, people and time management, CRO selection, BID meetings, feasibility and site selection, CRO, vendor and budget management.