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Capgemini
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Global Study Supply Support

Global Study Supply Support

Capgemini

6 - 11 years

20 - 30 Lacs

hyderabad

Posted:2 weeks ago| Platform:

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Skills Required

irt clinical trials endpoint etmf veeva vault drug stock management trial master file gmp clinical study report gdp clinical supplies gxp shipment planning

Work Mode

Hybrid

Job Type

Full Time

Job Description

Job Title:

Role Overview

Provide operational support to Clinical Supply Chain Study Leaders for multiple studies across all phases (set-up, follow-up, closure).
Work independently and collaborate with multiple leaders and cross-functional teams.
Key tasks include:

Preparing and tracking transfer orders.
Managing stock reconciliation.
Performing quality checks.
Preparing documentation for labeling and shipments.
Monitoring needs for destruction.
Archiving documents in the electronic Trial Master File.

Key Responsibilities

Support clinical supply chain operations for global studies.
Ensure compliance with regulatory standards and protocols.
Maintain accurate documentation and inspection readiness.
Communicate effectively with supply chain leaders, operational teams, and outsourcing partners.
Adapt to changing priorities in a fast-paced environment.

Must-Have Skills & Qualifications

Education:
Pharmaceutical or health-related degree (Bac+3, Bac+5, or PhD).
Experience:

Clinical supply support or logistics for clinical trials (Phase I-IV).
Digital tools and supply chain software.

Knowledge:

Regulatory standards (quality, safety, documentation).
Investigational product management (kit types, shelf life, depot management, distribution, reconciliation, returns, destruction).

Technical Skills:

Proficiency with tools: IRT (e.g., Endpoint, Suvoda), Smart Supplies, Veeva Vault.
Documentation and quality check skills.

Language:
Fluent English for communication with stakeholders.

Key Competencies

Attention to detail and organizational skills.
Ability to manage multiple priorities and work collaboratively in a multicultural environment.
Strong problem-solving and adaptability skills.
Comfort with digital tools and documentation processes.

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