Clinical Project Manager

Client

Several clients are looking for (experienced) Clinical Project Managers. Clients are CROs, pharmaceutical companies, … and located in different regions (e.g. Brussels region, Antwerp region).

Main purpose

The Clinical Project Manager is responsible for effectively planning, managing and executing the participation for a given clinical trial and ensuring that timelines, budget, resources and quality standards are met in full compliance with local and international SOPs and with relevant legislation.

Tasks

  • Keeping timelines for Clinical Trial and responsible for budget development and maintenance as well as contractual support.
  • First point of contact for respective clinical study
  • Operational implementation of Clinical trial protocol.
  • Strategic and operational decision making with regards to clinical programs
  • Overseeing the conduct of a clinical trial to insure the quality and integrity of data and safe and proper management of study parameters and review CRA reports.
  • Preparing, translating, reviewing and completing study documentation (Communication Plan, Monitoring Plan, Protocol, ICF, IB, …)
  • Facilitating study reporting and preparation of follow-up activities
  • Assist with Investigator meeting training (GCPs, protocol, IMP, …)

Requirements

  • Medical or scientific background.
  • Fluent in Dutch, French and English
  • Proven experience with setting up, conducting and managing clinical studies according to GCP/ICH.

 

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