Clinical Research Manager (m/f) – geschlossen

  • Position zu besetzen ab 2. Juli 2018
  • Permanent-ID OCR-FL-2018-1079
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Freelance/Contracting, Pharma

Tasks

  • Accountable for day to day activities of all aspects for the management of local company-sponsored studies, including study plans, timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
  • Accountable for the oversight of IST/ISS granted by Merck, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
  • Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
  • Develop and monitor study budget and timelines
  • Monitor work to ensure quality
  • Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
  • Contribute to the planning and set-up of a study and provide planning parameters, Support early access programs on the country level
  • Manages the budget for all local clinical studies and Global Phase IV studies assigned, as well as the IST/ISS grants.

Skills

  • CRO > 5 yrs.
  • Clinical Research > 5 yrs.
  • Trial management > 5 yrs.
  • Work with external CRO – nice to have
  • Pharmaceutical industry – nice to have

Additional Information

Location: Darmstadt

Project start: July 2018

Duration: 30.06.2018

Availability: 5 days/week,
100% on-site support

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