Description de fonction

040-2019 Project Manager CTSU (Clinical Trial Support Unit) - CDI - 38h (h/f)

Détails de la société

The CTSU is a department of Belgium’s world-renowned cancer centre, Institut Jules Bordet, and has many years’ experience in the design, implementation and conduct of phase II and III and other clinical trials. Located in Brussels, Belgium, right in the heart of Europe, the team consists of about 60 members and works in collaboration with medical specialists

Fonction

The primary role of the Project Manager is to administer, maintain and co-ordinate various logistical aspects of clinical trials in accordance with standards procedures and guidelines. The PM acts as a pivotal point of contact for the study team.

Tasks and Responsibilities:

  • Organise study set-up activities;
  • Ensure that milestones, deliverables, quality and timelines are met within budget and in accordance with regulatory and contractual requirement;
  • Write or contribute to preparation of study protocol, informed consent forms and any other clinical research related documents;
  • Coordinate investigational medicinal product (IMP) supplies
  • Assist with Ethics Committees and/or Competent Authorities submissions and filing necessary supportive documentation
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH GCP regulations and study specific manuals and procedures
  • Report risks/issues that can affect the study and work to the study team to implement corrective actions
  • Ensure appropriate filing of study documents in the trial master file

Profil

Essential qualifications and skills:

  • Holds a master degree in the scientific, biomedical or paramedical field
  • Experience of working on clinical trials with knowledge of GCP
  • Excellent command of written & spoken English, as well as French or Dutch.
  • Ability to make decisions
  • Team player, strong diplomatic skills
  • Willing to bring his/her contribution in a demanding academic environment

Offre

For more information on the available position and environment, please https://ctsu.bordet.be or www.bordet.be.

  • Publiée le:mar. 9 avril 2019
  • Lieu: Institut Jules Bordet
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