Clinical Project Assistant
Sanofi
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Job Description
Location: Hyderabad, India
Job ID: Not specified
Company: Sanofi
Employment Type: Full-time
About the Role
Sanofi is a global biopharmaceutical leader dedicated to advancing scientific innovation and delivering life-changing treatments across immunology, chronic diseases, rare disorders, vaccines, and more. The Clinical Project Assistant (CPA) role supports clinical operations by ensuring high-quality documentation, study setup, process coordination, and stakeholder collaboration across global studies.
This position sits within Sanofi Business Operations (SBO) in India, a centralized organization supporting global clinical, medical, commercial, and R&D functions.
Role & Responsibilities
eTMF & System Support
- Support setup and administration of eTMF, IMPACT CTMS/eSTRA, and other clinical operations tools.
- Ensure adherence to protocols, GCP guidelines, and SOPs.
- Assist with document collection, archiving, uploading, and quality control throughout the study lifecycle.
Study Operations & Coordination
- Coordinate project activities, track progress, and support execution against timelines and milestones.
- Draft, update, and maintain key study documentation such as tools, manuals, SOPs, SharePoint content, and training guides.
- Maintain study portals and update versions as required.
- Support tracking of budgets and site payments.
Prepare meeting minutes, reports, and stakeholder updates; conduct meetings when needed.
Educational Qualification
- Education: Bachelor’s degree in Life Sciences or a related field.
- Experience:
- Minimum 3+ years in Clinical Research & Development.
- Strong experience in eTMF document management is required.
- Minimum 3+ years in Clinical Research & Development.
- Soft Skills:
- Excellent verbal and written communication skills.
- Ability to maintain confidentiality and manage sensitive data.
- Strong relationship-building and stakeholder management skills.
- Excellent verbal and written communication skills.
- Technical Skills:
- Strong understanding of ICH-GCP, clinical trial methodologies, and regulatory guidelines.
- Proficient in Microsoft Office and comfortable with emerging digital tools.
- Methodical approach to work and strong task prioritization skills.
- Strong understanding of ICH-GCP, clinical trial methodologies, and regulatory guidelines.
Effective cross-functional collaboration experience.
Location
Hyderabad, India
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