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