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 curve…) in order to translate the ES into:
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
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,
Strong organization skill,
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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