Clinical Trial Supply Manager

Reference Number: 896115-W
Type of placement: Contract
Location: CH, NW

Introduction:

The Clinical Trial Supply Manager (CTSM) defines and executes an optimal clinical trial supply strategy for a clinical trial including effective risk management to ensure supply continuity to patients. The CTSM is the single point of contact in Global Clinical Supply at trial level for the Clinical Trial Team. The CTSM is responsible for clinical trial supply deliverables within Global Clinical Supply and all other relevant associated sub-functions, maintaining Quality and Compliance through all activities. Furthermore, the CTSM has operational end to end responsibility for assigned activity. The CTSM leads and manages all project and local network activities and participates in cross-functional teams

Main Responsibilities:

  • Represents GCS as a core member in the Clinical Trial Team; defines and advises the Clinical Trial Team on the optimal clinical trial supply strategy in terms of, but not limited to, packaging design, technical and timeline feasibility, efficiency and risk management;
  • Reviews overall clinical trial protocol/protocol amendments, provides inputs to develop optimal packaging design, clinical trial supply design and visit schedule;
  • Creates and maintains complete and accurate clinical supply demand for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate overage and by using defined processes and systems;
  • Identifies, assesses and proactively communicates supply risks to all relevant stakeholders along with appropriate mitigation strategies to ensure supply continuity;
  • Collaborates with all relevant line function partners for country submission and approval timelines to develop optimal supply strategy;
  • Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions;
  • Triggers and tracks shipments of IMPs from central depot to regional hubs and local depots;
  • Develops, maintains and executes an optimal resupply strategy with proactive planning, appropriate lead-time and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.

Qualifications and Experience:

  • University degree in science, engineering or equivalent;
  • Min. 8 years of practical experience in chemical / pharmaceutical industry, min. 5 years of experience in clinical trial supply management;
  • Good expertise in related field;
  • Good knowledge about the Drug Development process;
  • Basic project management, good organization and planning skills;
  • Knowledge of relevant regulations (e.g. GMP, HSE etc.);
  • Demonstrates problem-solving and idea generation skills;
  • Fundamental Leadership skills;
  • Very good communication, negotiation and interpersonal skills. Ability to work in interdisciplinary teams;
  • Fluent in English;
  • Relevant working/residency permit or Swiss/EU-Citizenship required.

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