Francois Caijo

Background

About Francois Caijo

Current position : Veeva - Senior Director, Strategy, Vault CDMS Responsible for growing and sustaining the European market for Veeva Vault CDMS and for delivering our overall Clinical Data Management System (CDMS) strategy, with specific responsibility to our Enterprise Sponsors- High-performing data management expert with R&D and clinical operations background- Strong knowledge of clinical and research data management, clinical IT & R&D operations processes, regulations and standards- Build / optimize organizations, data management processes, data governance, outsourcing models to maximize business needs and efficiencies- Ability to implement and govern outsourcing models (Functional Service Provider, Business Process As A Service) especially with offshored partners- Previous Experiences : Pharmaceutical education after a Master of Health Management Engineering 15 + years experience of global team line-management including managers, data managers, database designers, clinical standards experts, data experts 5+ years experience in data office management and data governance as Data Officer in several organization 5+ years experience in coordinating and governing overall clinical IT systems (CDMS, CTMS, EDMS, SAS.) 5+ years experience as Senior Clinical Data Manager: from database set-up to database lock (all DM activities) in Phase II and Phase studies. Cardiology, Neurology, Endocrinology. Expertises : Management and organizational skills, ability to anticipate job evolution, Outsourcing strategies & models, Change management, IT systems and validation Able to define project strategy according to solid DM expertise : Worked with both paper based CRF, EDC systems, ePROs/eCOAs, digital approaches Clinical IT Negociation and leadership skills through several project teams participation. Budget, Planning and human ressources management. Individual developments plans for collaborators and identification of talents. Solid knowledge of data management & clinical regulations (GCP, ICH)