Clinical Trial Supply Manager

Reference Number: 895637-W
Type of placement: Contract, Contract, 6 months
Location: Switzerland, North West

Introduction:

For one of our clients, we are currently looking for a Clinical Trial Supply Manager.

Main Responsibilities:

  • Clinical Supplies Demand, Packaging and Logistics
    • Ensure timely delivery of clinical trial supplies for assigned projects and studies
    • Agree on project scope with the Clinical and the CMC teams, perform risk assessment and elaborate contingency
    • Advising customers from the clinical development and medical marketing functions with regard to packaging and labelling of study drugs for clinical purpose
    • Development of study specific packaging and labelling configuration
    • Coordinate the production activities with regards to primary packaging (when appropriate), secondary packaging, labelling, and randomization at the supplier level
    • Ensure that the operative clinical trial supply tasks are delegated to the service providers and minimize own involvement on the operational level
    • Key contact with the suppliers with regards to packaging for studies and randomization
    • Ensure coordination between all functions involved in clinical supply such as Clinical Development, Medical Marketing, Biometrics, Regulatory Affairs, Quality Management, Technical Operations, etc.
    • Ensure proper batch allocation and compliant process of packaging and labelling activities
    • Set-up the worldwide study distribution to ensure proper distribution to the final consignees (investigational sites)including the availability of import license or notifications (study / country / site specific).
    • Work on organizational projects aiming at improving the packaging, labelling, and distribution processes in terms of quality, productivity, and costs
    • Participation in the development and maintenance of internal quality rules and documents
    • Organize proper hand-over of projects including documentation as filed in the project specific TMF
  • Business Processes and Technical Documentation
    • Approve the packaging and logistics service agreements with the clinical trial material suppliers and corresponding invoices
    • Ensure filing and archiving of the CTS part of the Trial Master File.
    • Regular update of the clinical supplies’ tracking and reporting using KPIs & annual reports

Qualifications and Experience:

  • University degree or equivalent working experience in life sciences
  • At least 2 years of experience in different fields of Clinical Trial Supply Management
  • Expert in understanding of all impacts of the relevant international current GMP, GDP, and GCP regulations
  • Excellent command of common study management tools
  • Team spirit
  • Flexible work attitude
  • Ability to lead the negotiation with all internal and external partners
  • Knowledge in risks, bottlenecks, and potential failure points within the clinical trial supply chain
  • Excellent command of English (written and spoken), one additional language, preferably German or French is an asset
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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