Clinical Project Manager M/F

Responsabilities Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing: Plan the clinical development program Prepare studies protocols, amendments and reports Prepare regulatory dossiers Manage relationships with investigators and opinion leaders Requirements Holder of additional training in methodology (CESAM, IUD, …) Successful experience of Clinical Project Manager in a pharmaceutical company or CRO 6-8 year’s experience in clinical development (Phase II and III) Experience in oncology or autoimmune inflammatory diseases would be a plus Experience in international development required Experience of the regulatory environment for clinical trials Experience of writing research reports and FDA regulatory dossiers (IND, NDA) and EMA Fluent in English Additionnal informations Permanent position, available immediately Based in Paris Salary & package to define according skills and experience