Sanofi Group Trial Supply Operations Manager, Bridgewater NJ in Bridgewater, New Jersey

The role of TSOM is to perform study set-up and follow-up tasks related to Clinical Supply Chain Operations (CSCO). The TSOM is leading the study at CSCO

He or she is the key contact for CTOMs in charge of the study.

  • Receives the ES/protocol, comments and contributes on IMP/NIMP sections.

  • Captures the requirements (countries list, recruitment curveā€¦) in order to translate the ES into:

  • IMP/NIMP/Devices forecasts

  • Packaging specifications with the CSPM,

  • IP/ancillaries and/or devices needs,

  • Survey to define strategy for supplying comparators and ancillaries,

  • Distribution specifications and strategy depending on participating countries

  • Manages the study risks and appropriate mitigation plans.

  • Set-up IRT if needed.

  • Provides Documentation input: protocol/monitoring plan/Pharmacy manual/Instructions for Use/ CRA presentations.

  • Initiates label process (form1) and supports addition labeling process when needed.

  • Manages treatment list.

  • Generates master study plans for packaging and distribution.

  • Monitors the variance between realization versus forecast and adapt the master study plans.

  • Supervises TSOM support activities

Required Skills

  • BAC+5 (Engineer or equivalent)

  • 2-3 years of experience in Pharmaceutical Industry

  • Experience in Supply Chain

  • Ability to work under tight deadline

  • A good relational sense,

  • Teamwork,

  • Strong organization skill,

  • Work autonomously

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