Clinical Project Manager
Proclincal are in partnership with a large pharmaceutical company in search for a talented Clinical Project Manager. In this role you oversee the clinical studies and work collaboratively with other departments to ensure good clinical practice.
- Design, implementation and coordination of clinical studies with the support of the Clinical Operations, Pharmacovigilance, Biometrics and Medical Writing departments:
- Planning the clinical development programme
- Writing protocols, amendments and study reports
- Writing regulatory files
- Managing relationships with investigators and opinion leaders
- Implementation and monitoring of actions to meet recruitment deadlines and good clinical practices
Skills and Requirements
- Holder of additional training in methodology (CESAM, DIU, ...)
- Successful experience as a Clinical Project Manager in a pharmaceutical laboratory or CRO
- 6 to 8 years of experience clinical development (phase II and III)
- Experience in oncology or in auto-immune inflammatory pathologies would be a plus.
- International development experience essential
- Control of the regulatory environment for clinical trials
- Experience in writing study reports and FDA (IND, NDA) and EMA regulatory dossiers
- Fluent English imperative
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.