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.

Job Responsibilities

• 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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