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eTMF Global Study Supply Support at Capgemini

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Capgemini

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

Hyderabad

2โ€“7 years

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Capgemini Engineering is hiring Global Study Supply Support (GSSS) professionals in Hyderabad. This role offers the opportunity to support global clinical trials (Phases Iโ€“IV), manage investigational product (IP) logistics, and ensure regulatory compliance.

If youโ€™re experienced in clinical supply chain management, GxP documentation, and IP logistics, this position is ideal for you. Join a world leader in engineering and life sciences services, where innovation meets purpose.


๐Ÿงฉ Key Responsibilities

As a Global Study Supply Support (GSSS), you will collaborate with Clinical Supply Chain Study Leaders (CSC SL) and cross-functional teams to ensure smooth study execution.

Study Setup

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

Study Follow-up

  • Track and manage shipment orders using supply systems.
  • Monitor stock levels and handle IRT interface failures.
  • Oversee expired IMP/AxMP destruction processes.
  • Manage temperature excursion data and financial tracking.
  • Ensure accurate data entry for packaging and distribution activities.

Study Close-out

  • Coordinate IP returns and destruction.
  • Manage IP reconciliation with IPM.
  • Generate CSR appendices and ensure study documentation closure.

๐ŸŽ“ Qualifications and Skills

  • Bachelorโ€™s or Masterโ€™s degree in Pharmacy, Life Sciences, or related fields.
  • 2โ€“7 years of experience in clinical trial supply management.
  • Knowledge of clinical protocols, GxP standards, and IP management.
  • Familiar with tools like eTMF, Veeva Vault, IRT (Suvoda, Endpoint, Almac, Parexel).
  • Strong attention to detail, documentation, and coordination skills.

๐Ÿ’ผ Tools Youโ€™ll Use

  • eTMF, Veeva Vault โ€“ Clinical documentation platforms
  • IRT Systems โ€“ Suvoda, Almac, Endpoint
  • QUALIPSO (CAPA Tool) โ€“ Quality management
  • TEX โ€“ Temperature excursion management

๐ŸŒŸ Benefits of Working with Capgemini Engineering

  • Be part of a global clinical research support team.
  • Work in a hybrid model combining flexibility and collaboration.
  • Gain exposure to cutting-edge pharmaceutical and biotechnological innovations.
  • Continuous learning and growth opportunities within a world-class organization.

๐Ÿ“ How to Apply

Application Link

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