Clinical Project Manager

Reference: HAR-16-018

Client

Our client is a CRO, located in the south of Brussels.

This function can be partially homebased.

Main purpose

The CPM is responsible for the management of the study according to protocol, ICH-GCP and all applicable requirements. He/She bears responsibility for the quality, timelines and budget.

Tasks

  • The CPM will be the first point of contact for all internal and external parties for the respective clinical studies.
  • The CPM  will manage projects according to the highest quality standards and within agreed timelines and budget.
  • He/she will train, coach and supervise the project team, as well as manage and coordinate any third parties involved in the trial.
  • He/she will be responsible for the development, translations and review of study documentation (e.g. protocol, communication and project plan, ICF, monitoring and other manuals)
  • Vendor contract negotiations and management are part of the CPM’s responsibilities (such as local partner CROs, data management and statistics, central lab, IWRS, translation agencies)
  • The CPM will organize and lead study meetings, e.g. investigator- and monitor meetings, study team meetings, meetings with 3rd parties.
  • He/she will report on the study status and progress versus budget and timelines towards Client’s management and sponsor.

Requirements

  • Scientific life sciences academic degree or comparable education
  • Fluent in English
  • Extensive experience as CPM, especially in phase I and phase II trials
  • Broad (by preference international) clinical trials experience  (different phases, different therapeutic areas, from feasibility till close-out)
  • Strong motivational and leadership skills
  • Able to keep strategic, high level overview
  • Strong initiative and ability to work with minimal supervision
  • Excellent time manager, able to manage multiple and varied tasks and prioritize workload with attention to detail
  • Pro-active attitude
  • Diplomatic and teamplayer
  • Excellent communication skills
  • Problem solver with good analytical capabilities
  • Accurate and well organized, acting in a structured way
  • Creative and “out of the box” thinker

 

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