Sanofi has announced an exciting opportunity for an experienced Central Clinical Research Associate (CRA) to join its Sanofi Business Operations (SBO) team in Hyderabad, India. This role offers professionals with clinical research monitoring experience the chance to work on global rare disease registries, clinical trial monitoring, study start-up, regulatory submissions, remote and onsite site management, and eTMF compliance.
If you have experience in clinical trial monitoring, ICH-GCP, site management, eCRF review, TMF, IRB/EC submissions, and clinical operations, this Sanofi Clinical Research Associate job could be an excellent next career move.
Job Details
| Details | Information |
|---|---|
| Company | Sanofi |
| Position | Central Clinical Research Associate (CRA) |
| Location | Hyderabad, India |
| Employment Type | Full-Time |
| Department | Sanofi Business Operations (SBO) |
| Experience | 5+ Years |
| Qualification | Degree in Pharmacy, Life Sciences or Scientific Discipline |
| Application Deadline | 24 September 2026 |
Key Responsibilities
The Central Clinical Research Associate (CRA) will support global registry studies and ensure compliance with regulatory and clinical research standards.
Major responsibilities include:
- Perform site feasibility and site selection activities
- Coordinate study start-up activities
- Collect regulatory and essential site documents
- Support Ethics Committee (EC) and Institutional Review Board (IRB) submissions
- Prepare and review informed consent documents
- Manage study start-up documentation within eTMF
- Conduct remote and onsite monitoring visits
- Perform Site Selection Visits (SSV)
- Conduct Site Initiation Visits (SIV)
- Conduct Routine Monitoring Visits (RMV)
- Conduct Close-Out Visits (COV)
- Review source documents and electronic Case Report Forms (eCRFs)
- Resolve clinical data queries with sites
- Coordinate with Data Management teams
- Monitor patient recruitment and retention
- Support site staff training
- Ensure GCP and regulatory compliance
- Review safety reporting processes
- Perform deviation analysis and CAPA implementation
- Maintain study trackers, dashboards and databases
- Support investigator payments
- Ensure TMF and eTMF compliance throughout the study lifecycle
- Participate in study meetings, audits and inspections
- Collaborate with vendors, investigators and global stakeholders
Required Qualifications
Candidates should possess:
- Degree in Pharmacy
- Life Sciences degree
- Scientific discipline qualification
Preferred educational backgrounds include:
- B.Pharm
- M.Pharm
- Pharm.D
- MSc Life Sciences
- Biotechnology
- Microbiology
- Biochemistry
- Clinical Research
- Other relevant Life Science disciplines
Experience Required
Applicants should have:
- Minimum 5 years of Clinical Research experience
- Clinical trial monitoring experience
- Global clinical project exposure
- Experience working within international matrix organizations
Experience in the following will be an advantage:
- Rare disease studies
- Observational studies
- Real World Evidence (RWE)
- Registry studies
Required Technical Skills
Ideal candidates should possess knowledge of:
- ICH-GCP
- Clinical Trial Monitoring
- Site Management
- Study Start-up
- eTMF
- Trial Master File (TMF)
- Remote Monitoring
- Onsite Monitoring
- Regulatory Compliance
- FDA & EMA Guidelines
- Ethics Committee (EC)
- Institutional Review Board (IRB)
- Health Authority submissions
- eCRF Review
- Query Management
- Source Data Verification
- CAPA
- Root Cause Analysis
- Safety Reporting
- Clinical Documentation
- Microsoft Office
Soft Skills
Sanofi is looking for professionals with:
- Excellent communication skills
- Stakeholder management
- Time management
- Project management
- Problem-solving abilities
- Ethical decision-making
- Adaptability
- Attention to detail
- Technical writing skills
Why Join Sanofi?
Employees at Sanofi enjoy:
- Global clinical research exposure
- Opportunity to work on rare disease registries
- International collaboration
- Career growth opportunities
- Modern clinical research environment
- Diverse and inclusive workplace
- Learning and development programs
- Exposure to global regulatory standards
- Opportunity to work with cross-functional teams
Who Should Apply?
This opportunity is ideal for professionals working as:
- Clinical Research Associate (CRA)
- Senior CRA
- Clinical Trial Monitor
- Site Management Associate
- Clinical Operations Specialist
- Clinical Project Associate
- Clinical Trial Coordinator
- Clinical Research Professional
- Site Management CRA
- Registry Study Coordinator
How to Apply
