Sanofi is inviting applications for the position of Clinical Project Assistant at its Hyderabad office. This is an excellent opportunity for experienced clinical research professionals with expertise in eTMF management, Trial Master File (TMF), clinical documentation, ICH-GCP compliance, and registry operations.

Candidates with experience in clinical trial documentation, TMF quality control, project coordination, and clinical operations can build a rewarding career with one of the world’s leading pharmaceutical companies.

If you have experience supporting clinical studies, maintaining inspection-ready Trial Master Files, and coordinating cross-functional clinical project activities, this Sanofi Clinical Project Assistant job could be your next career move.

Job Details

About Sanofi

Sanofi is a global healthcare company dedicated to discovering, developing, and delivering innovative medicines and vaccines. Through Sanofi Business Operations (SBO) in India, the organization supports global medical, clinical development, vaccines, specialty care, and R&D operations by delivering high-quality operational excellence.

The Clinical Project Assistant will work closely with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), registry teams, and study sites to ensure efficient management of clinical documentation and registry operations.

Key Responsibilities

The selected Clinical Project Assistant will be responsible for:

• Supporting electronic Trial Master File (eTMF) setup and maintenance
• Managing Trial Master File (TMF) documentation throughout the study lifecycle
• Uploading study documents and performing primary Quality Control (QC)
• Maintaining inspection-ready TMF according to ICH-GCP requirements
• Coordinating registry project timelines and milestone tracking
• Supporting project management and administrative activities
• Preparing meeting minutes and project correspondence
• Managing TMF archiving, reconciliation, and document filing
• Supporting audits and regulatory inspections
• Tracking project-specific e-learning compliance
• Coordinating onboarding and system access for project team members
• Updating Registry SharePoint documentation
• Supporting project budget tracking and site payment activities
• Ensuring proper document classification within eTMF systems

Required Qualifications

Candidates should possess:

• Bachelor’s Degree in Life Sciences or related discipline
• Minimum 3 years of clinical research experience
• Hands-on experience in eTMF document management
• Experience with Trial Master File maintenance
• Strong understanding of clinical trial documentation
• Knowledge of registry studies
• Experience supporting clinical project teams

Required Skills

Ideal candidates should have experience in:

• eTMF Management
• Trial Master File (TMF)
• Clinical Trial Documentation
• Registry Operations
• ICH-GCP Guidelines
• Clinical Research
• Clinical Project Coordination
• Quality Control (QC)
• SOP Compliance
• SharePoint
• Microsoft Office
• Audit Readiness
• TMF Archiving
• Cross-functional Collaboration
• Clinical Operations

Preferred Candidate Profile

Sanofi is looking for professionals who demonstrate:

• Strong organizational skills
• Excellent attention to detail
• Effective communication skills
• Ability to manage confidential clinical data
• Strong project coordination abilities
• Good prioritization and multitasking skills
• Excellent stakeholder management
• High proficiency in written and spoken English

Salary (Expected)

Based on current market standards for Clinical Project Assistant roles in Hyderabad with 3–5 years of experience:

Estimated Salary: ₹8,00,000 – ₹13,00,000 per annum (CTC)

Actual compensation will depend on candidate experience, skills, and Sanofi’s internal compensation policies.

Why Join Sanofi?

Working at Sanofi offers several advantages:

• Permanent full-time opportunity
• Global pharmaceutical organization
• Exposure to international clinical trials
• Registry and clinical operations experience
• Career growth in Clinical Research
• Global quality standards
• Cross-functional collaboration
• Learning and development opportunities
• Inclusive workplace culture
• Opportunity to work with global clinical teams

Who Should Apply?

This opportunity is suitable for professionals working as:

• Clinical Trial Assistant (CTA)
• Clinical Project Assistant
• Trial Master File Specialist
• TMF Associate
• eTMF Specialist
• Clinical Documentation Associate
• Clinical Operations Associate
• Registry Operations Associate
• Clinical Research Coordinator
• Clinical Project Coordinator

How to Apply

Application Link