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Clinical Supply Manager

Alentis Therapeutics · Allschwil

🇬🇧 English
IRT/EDC systems

Job description

About the role

The Clinical Supply Manager will oversee the planning, coordination and timely delivery of investigational medicinal products (IMP), placebos, standard‑of‑care and ancillary supplies for global clinical trials. This role ensures that supply strategies align with study protocols, enrollment forecasts and regulatory requirements to support Alentis Therapeutics’ oncology and fibrosis programs.

Key responsibilities

  • Develop demand forecasts and supply plans based on study protocols and enrollment projections.
  • Design and execute supply strategies for trial medication and ancillary items in partnership with clinical and CMC teams.
  • Manage procurement, packaging design, blinding setup and global distribution, including depot selection.
  • Maintain trial medication inventory, monitor expiry dates and coordinate resupply with CMC.
  • Conduct user‑acceptance testing of IRT/EDC systems and manage IRT for inventory tracking.
  • Serve as primary contact for labeling and packaging vendors and clinical sites regarding trial supplies.
  • Prepare and approve master and local label texts, oversee translations and ensure compliance with SOPs.
  • Monitor drug reconciliation, recall, quarantine, return and destruction processes.
  • Oversee import/export operations, vendor performance and implement improvement plans as needed.
  • Report progress and updates to line manager regularly.

Required profile

  • Experience managing clinical trial supplies and coordinating with cross‑functional teams.
  • Familiarity with regulatory requirements for IMP handling and labeling.
  • Strong organizational and documentation skills.

Required skills

  • IRT/EDC systems

Questions fréquentes

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Published 3 months ago

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Alentis Therapeutics

Allschwil