Clinical Trial Drug Supply Manager

Reference Number: 895918-W
Type of placement: Contract, Contract
Location: Switzerland, North West

Introduction:

The Clinical Trial Supply Manager defines and executes an optimal clinical trial supply strategy for the company clinical trial portfolio including effective risk management to ensure supply continuity to patients. Operational end to end responsibility for all aspects of clinical supply management including packaging, labeling, monitoring inventory levels, and distributing through the interaction with internal and external supply partners to ensure supply of clinical trial materials are sufficient and ready to support worldwide clinical trials. The CTSM is the single point of contact at trial level for the Clinical Trial Team and will work closely with Clinical Operations, Project Management, Technical Operations (TO) and Quality (QA).

Main Responsibilities:

  • Responsible for logistics to support the labeling, packaging and shipment of clinical drug supplies to depots/clinical trial sites as well as other clinical supplies activities necessary to support clinical trial objectives and timelines
  • Primary liaison for drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies
  • Work with third party vendors and interface with TO to support Production Planning and Distribution; develop demand forecast of all drug supply needs and work with TO to ensure that goals are met
  • Work with Clinical Operations, TO, and supply chain planning on master production schedule so timing of clinical trial drug needs are met
  • Maintaining of collaborative relationships with third party vendors to assure the complete scope of drug supply activities remains connected with operations and compliant with quality requirements
  • Monitoring and tracking shipments to ensure smooth transit through the logistical path – including international shipping and import licenses
  • Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with TO, clinical, regulatory departments and QA
  • Overseeing vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives, and issue resolution
  • Developing drug supply management training materials for investigational sites
  • Developing pharmacy manual in conjunction with relevant cross-functional leads
  • Generating/reviewing processes as required and ensures compliance to relevant SOPs
  • Leading evaluation and oversight of IRT vendors

Qualifications and Experience:

  • At least 5 years of experience in drug supply for clinical trials
  • Organized, quality focused
  • Fluent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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