Global Study Supply Support (GSSS)

Global Study Supply Support (GSSS)

Location : Hyderabad

Experience : 2–7 years

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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.