Clinical Project Manager M/F
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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
- 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
- Based in Paris
- Salary & package to define according skills and experience
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