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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, Clinical Research

  • Contact email:

    amandine_planche@oxfordcorp.com

For one of our clients located in the Hainaut, we are looking for an experienced Clinical Project Manager (6-9 months assignment). 

Job Description

As Clinical Project Manager, you will have several responsibilities.

Responsibilities
  • You are in charge of the Management and coordination of clinical trials (phase II and III)
  • You participate to study design and protocol development
  • You are responsible for the Scientific and medical writing - study related documents: protocols, IB, ICF, CRF, ...
  • You are responsible for the preparation of regulatory documents/submission files to EC (CA)
  • You are responsible to manage Site Relationship: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings
  • You manage CRO and monitoring activities
  • You review clinical trials data and will support in the preparation of clinical study reports
  • You contribute to Safety Management: reporting, notification of safety events – follow up and safety report preparation
  • You are responsible for the development of credible relationships with KoL, Investigators, and key stakeholders
  • You review medical literature and related new technologies in close collaboration with other departments (preclinical, regulatory, production, QC, IP…)
Requirements
  • You have an advanced scientific degree (PhD, MD) 
  • You have at least 2-4 years of experience as Clinical Project Manager and 1-2 years of experience in Study Monitoring (as a CRA), preferably in phase II and III trials
  • You are fluent in English
  • You have a strong knowledge of ICH-GCP principles
  • You are autonomous  and a real team player
  • You have strong interpersonal and communication skills
  • You are able to work within Start up and Biotech environment in a quickly growing structure
  • You are reactive to deadlines, pro-active, dynamic and problem solving