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Clinical Project Assistant (TMF) – Sanofi

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Sanofi

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

Hyderabad

3 years

Verified Job

Online Application
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Are you passionate about clinical research and looking to build a career with a global pharmaceutical leader? Sanofi India is inviting applications for the position of Clinical Project Assistant (CPA) in Hyderabad. This full-time role offers the opportunity to work with international clinical teams and support projects that advance healthcare innovation across the globe.

If you have hands-on experience in clinical trial documentation, eTMF management, and a strong grasp of ICH-GCP guidelines, this could be the perfect next step in your career.


About Sanofi Business Operations (SBO)

Sanofi Business Operations (SBO) is a global hub in India supporting Sanofi’s Specialty Care, Vaccines, General Medicines, and R&D functions. The team collaborates across multiple therapeutic areas, driving operational excellence and centralizing clinical and medical activities worldwide.

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Key Responsibilities

As a Clinical Project Assistant, you will:

  • Provide administrative and documentation support for clinical trial setup, execution, and closure.
  • Manage and maintain the electronic Trial Master File (eTMF) and IMPACT CTMS/eSTRA tools.
  • Coordinate study timelines, prepare meeting minutes, track deliverables, and ensure regulatory compliance.
  • Support site payments, budget tracking, and internal audit readiness.
  • Assist with onboarding new team members and monitoring mandatory training completion.
  • Collaborate with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and cross-functional teams globally.
  • Ensure compliance with Good Clinical Practices (GCP) and company SOPs.

Qualifications and Experience

Education:

  • Bachelor’s degree in Life Sciences or a related field.

Experience:

  • Minimum 3 years of experience in Clinical Research & Development.
  • Strong understanding of ICH-GCP guidelines, clinical trial methodologies, and eTMF management.

Technical Skills:

  • Proficiency in Microsoft Office Suite.
  • Familiarity with clinical data systems, CTMS, and document control tools.
  • Strong organizational and multitasking abilities.

Soft Skills:

  • Excellent written and verbal communication.
  • Strong collaboration and stakeholder management.
  • High attention to detail and confidentiality.

Why Join Sanofi?

  • Be part of a global healthcare leader committed to improving patient outcomes.
  • Work in a collaborative, inclusive, and diverse environment.
  • Gain exposure to cutting-edge digital tools and global clinical operations.
  • Competitive compensation and career growth opportunities.

How to Apply

Application Link

Clinical Project Assistant (TMF) – Sanofi
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