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Clinical Data Manager

Coordinating Clinical Data Manager - someone who sets up, standardizes and manages programs for clinical data gathered from clinical studies done by several partner CRO's of this pharmaceutical and biotechnological, rising power-house.

Job Description

For a company that develops their own, knock-your-socks-off, therapies against a broad spectrum of diseases, we are looking for a Clinical Data Manager. In this position you will be the main point of contact for clinical data managers, coordinators and research associates at the CRO's that the company works with. To ensure standardization of data for all entities, you will set up and program the clinical data programs / databases (Rave, etc.), and guide the local clinical staff at the CRO's towards using these according to ICH-GCP guidelines. You keep oversight on all data management activities within several projects at once.

Responsibilities

  • Set up and manage the clinical data program / database (Rave).
  • Standardize data capture and reporting at all partner CRO's and their data managers.
  • Safeguard clinical study data integrity by ensuring ICH-GCP guidelines are followed.
  • Contribute to constant process improvement and adjustment.
  • Serve as the main point of contact for collaborating parties at CRO's and other clients.
  • Oversee data capture and reporting, coordinating and training personnel where needed.

Requirements

  • At least a finished MSc degree within biomedical sciences, biostatistics, clinical research or similar.
  • Senior level of experience in clinical program data management.
  • Experience with statistics and/or programming is highly desirable.
  • Coordinating and managing capabilities
  • Excellent communication in English (Dutch is a plus)
  • Analytical, pragmatic, clear communication, direct.

Benefits

  • Contract: Long term (1 year contract followed by permanent)
  • Salary: €60k tot €100k per year
  • Hours: 32 - 40 hours, full time preferred
  • Location: Utrecht area
  • Vacancy number: 17060


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