About the Job
Senior Clinical Project Manager - Paris - up to €70,000
Optimus Life Sciences are working with a medium Sized Biotechnology company specialising in Oncology. Based in Paris, they are looking for an experienced Clinical Project Manager to join their expanding team in Global ClinOps. This position will be responsible for a number of Phase III trials in over 30 countries, with over 100 sites.
Design, implementation and coordination of clinical studies with the support of the departments Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing:
- Plan the clinical development program.
- Write protocols, amendments and study reports.
- Prepare regulatory files.
- Manage relationships with investigators and opinion leaders.
- Implementation and monitoring of action to meet deadlines recruitment and Good Clinical Practice.
- University Degree in Life Sciences.
- 5 years' experience in clinical development (Phase III).
- Experience in oncology or autoimmune inflammatory diseases is a plus.
- Experience writing research reports and FDA regulatory filings (IND, NDA) and EMA.
- Strong English language skills are imperative.