Proclinical Staffing

Clinical Project Manager

Location
Île-de-France, France, Paris
Salary
Negotiable
Posted
15 Feb 2021
Closes
01 Mar 2021
Ref
35688
Contact
Manon Madelenat
Hours
Full Time
Contract Type
Permanent
Experience Level
Management
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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