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Clinical Project Manager

  • Location:

    Gosselies, Belgium

  • Contact:

    Amandine Planche

  • Job type:

    Contract

  • Contact phone:

    +32 2 588 16 07

  • Industry:

    Biotechnology, Pharmaceutical

  • Contact email:

    amandine_planche@oxfordcorp.com

For one of our clients located in the Hainaut, we are urgently looking for an experienced Clinical Project Manager, available for a 6 months assignment, starting from April 1st at the latest.

Job Description

As Clinical Project Manager, you have several responsibilities.

Responsibilities

  • Management and coordination of phase II and III clinical studies.
  • Participation to study design and protocol development
  • Scientific and medical writing: study related documents (protocols, IB, ICF, CRF, …)
  • Preparation of regulatory documents/submission files to EC (CA)
  • Management of relationship with sites: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings
  • CROs management and monitoring activities management
  • Review of clinical trial data, support in preparation of clinical study reports
  • Contribution to Safety Management: reporting, notification of safety events, follow up and safety report preparation
  • Development of credible relationships with KoL, Investigators, and key stakeholders; 
  • Review of medical literature and related new technologies, and working in close collaboration with other departments (preclinical, regulatory, production, QC, IP…)

Requirements

  • You have a Scientific degree (Master, PhD or MD) 
  • You have at least 2 years of experience as Clinical Project Manager and 1-2 years of experience in study monitoring as a CRA within a pharma industry or biotech environment
  • You have a strong knowledge of ICH-GCP requirements
  • You are fluent in English and in French. Knowledge of Dutch is an asset.
  • You are autonomous, a real team player and you have strong interpersonal and communication skills
  • You are reactive to deadlines, pro-active, dynamic and problem solving