Excelya

Clinical Supply Manager

Excelya

full-time

Posted on:

Origin:  • 🇫🇷 France

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Manage end-to-end logistics of investigational medicinal products (including placebos) for global clinical trials
  • Oversee the supply chain for clinical materials and biological samples required in international studies
  • Centralize clinical supply needs (IMPs, clinical supplies, biological analyses) and establish a monthly planning shared with the industrial department and subcontractors
  • Act as the main interface between clinical teams and cross-functional units (pharmacy coordination, quality control, release, procurement, regulatory, legal, subcontractors)
  • Draft or coordinate the drafting of traceability documents related to clinical supply logistics (shipping requests, returns, AoR, etc.), or supervise these activities when outsourced
  • Supervise and monitor subcontracted activities (CROs, CMOs) related to IMP packaging, clinical supply, and biological sample storage
  • Investigate and analyze deviations or issues with subcontractors (secondary packaging, sample storage) and implement CAPAs
  • Ensure compliance with company SOPs, GMP/GCP, and all applicable regulatory requirements
  • Contribute to regulatory intelligence related to clinical supply chain activities and ensure process optimization
  • Provide regular reporting and proactively escalate risks or delays impacting study timelines

Requirements

  • Proven experience in managing international clinical operations
  • Experience in managing subcontractors (CROs/CMOs) and coordinating cross-functional teams
  • Solid knowledge of GMP, GCP, and regulatory requirements for IMPs and clinical supplies
  • Proficiency with supply chain planning tools and documentation systems
  • Degree in Life Sciences or related field
  • Proficiency in both English and French (written and spoken)