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Clinical Project ManagerRef: DT24097

Salary:€50000 - €70000 per annum

Added:14 May 2019

Region: France

Sector: Pharmaceutical

Sub Sector: Clinical Research

Missions: Design, implementation and coordination of clinical studies with the support of Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing departments: * Plan the clinical development program * Draft protocols, amendments and study reports * Prepare regulatory files * Manage relationships with investigators and opinion leaders * Implementation and follow-up of actions to meet recruitment deadlines and good clinical practice Profile: * Additional training in methodology (CESAM, IUD, ...) * Successful experience as a Clinical Project Manager in a pharmaceutical or CRO laboratory * 6 to 8 years of clinical development experience (Phase II and III) * Experience in oncology or in autoimmune inflammatory diseases * Experience of international development required * Control of the regulatory environment for clinical trials * Experience in the drafting of FDA (IND, NDA) and EMA * Fluent English

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