Global Study Supply Support (GSSS)

Global Study Supply Support (GSSS)

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Join a team that supports global clinical trials across phases I to IV, ensuring investigational product (IP) supply and compliance with regulatory standards. As a GSSS, you’ll play a key role in operational excellence, working closely with Clinical Supply Chain Study Leaders (CSC SL) and cross-functional teams.

Your Role

As a Global Study Supply Support (GSSS), you will support the Clinical Supply Chain Study Leader (CSC SL) throughout the lifecycle of clinical studies—from setup to close-out. You’ll manage investigational product logistics, documentation, and compliance activities, ensuring smooth execution of clinical trials.

In this role, you will:

Study Set-up

• Manage Trial Master File (TMF) documentation and ensure inspection readiness.
• Prepare shipment documentation including customs and country-specific requirements.
• Support Clinical Supply Packaging Order (CSPO) management.

Study Follow-up

• Enter and track shipment orders in supply systems.
• Monitor stock levels and IRT interface failures.
• Manage expired IMP and AxMP destruction processes.
• Extract temperature excursion data and support financial tracking.
• Ensure accurate data entry for packaging and distribution.

Study Close-out

• Coordinate returns and destruction of IP.
• Manage IP reconciliation with IPM.
• Generate Clinical Study Report (CSR) appendices.
• Ensure proper study documentation closure.

Your Profile

• Strong understanding of clinical trial protocols, regulatory requirements (GxP), and investigational product management.
• Familiarity with patient randomization, dosing regimens, and cohort management.
• Experience in IP logistics including kit types, shelf life, depot management, and reconciliation.
• Detail-oriented with strong documentation and coordination skills.
• Ability to work independently across multiple studies and stakeholders.

Tools You’ll Use

• eTMF, Veeva Vault
• RAID, IRT (Suvoda, Endpoint, Almac, Parexel)
• Clicks, QUALIPSO (CAPA tool)
• TEX (Temperature Excursion Management Tool)

What You’ll Love About Working Here

• Be part of a global team driving innovation in clinical research.
• Work in a collaborative environment with opportunities for learning and growth.
• Contribute to life-changing therapies by ensuring clinical supply chain excellence.

About Us

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.