Clinical Project Manager M/F

Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing:Plan the clinical development programPrepare studies protocols, amendments and reportsPrepare regulatory dossiersManage relationships with investigators and opinion leadersRequirements:Holder of additional training in methodology (CESAM, IUD, …)Successful experience as a Clinical Project Manager in a pharmaceutical company or CRO6-8 years of experience in clinical development (Phase II and III)Experience in oncology or autoimmune inflammatory diseases would be a plusExperience in international development requiredExperience with the regulatory environment for clinical trialsExperience in writing research reports and FDA regulatory dossiers (IND, NDA) and EMABased in ParisSalary & package to be defined according to skills and experience #J-18808-Ljbffr