Posted:3 days ago|
Platform:
Work from Office
Full Time
JoB Description
GSSS (Global Study Supply Support)
The role of the Global Study Supply Support (GSSS) is to provide support to the Clinical Supply Chain Study Leader (CSC SL) with minimal supervision. The GSSS works on iterative tasks during the set-up/follow-up/Closure phase of the clinical studies in phase I to IV. He/she works with several CSC SL and several studies.
The expected knowledge described below are expected
- Understanding of clinical trial design, protocols, regulatory requirements (GxP)
- Understanding of clinical endpoints, patient randomization processes, study arms, dosing regimens, cohort management, stratification factors
- Understanding of investigational product management in clinical trial including kit types, shelf life, IMP production plan, depot management, IMP distribution, IMP reconciliation, returns/destruction.
Detailed deliverables:
Interaction with other departments:
And by phase study :
Study Set-up
Study Follow-up
Study Close-out
Tools
Capgemini
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