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Clinical Trial Manager

13/05/2020
- Mont-Saint-Guibert

Job content

Job purpose is to drive all assigned clinical operations’ activities related to the clinical studies from protocol summary, study site selection and regulatory activation process to Clinical Study Report:

  • Select and activate chosen study sites, establish and maintain an excellent relationship with site investigators and research teams
  • Create and update activities in overall project plan on a regular basis to assure appropriate outcome of clinical trial projects in terms of scope, timelines and objectives.
  • Coordination of assigned CRA monitoring activities
  • Ensure study quality/GCP compliance to deliver a rigorous patient data
  • Partner with Clin Ops Director and provide oversight to all vendors or study delivery team, ensuring timely delivery of milestones and budget compliancy
  • Propose and implement study process improvements; Participate in the preparation, updating and training of SOPs
  • Liaise with manufacturing, central lab, and other study project stakeholders as needed
  • Prepares all external and internal documentation for assigned trials ensuring it is completed in accordance with the study protocol, internal SOP’s and GCP requirements (e.g., Patient Informed Consent Forms, Monitoring Plans, Project Plans)
  • Works with the Clin Ops Team to develop and maintain study timelines
  • Responsible for ensuring vendors deliver according to scope of work and review/approve vendor invoices
Profile
  • Degree in Life Science, biological science, or related area: or equivalent relevant experience acquired within life science industries.
  • 2-4 years’ experience in project management in early phase oncology/haematology trials, prior small start-up company experience in biotechnology highly desirable
  • Strong knowledge of ICH and GCP rules and of the complete clinical trials process
  • Proven ability to manage complex projects
  • Flexibility to re-prioritize workload to meet changing timelines
  • Good communication skills; fluent in English. Dutch/ French is an asset
Contact

Aline Vandermeeren 0497 715 810