Sanofi is inviting applications for the position of Clinical Data Specialist at its Hyderabad location. The role is part of Sanofi Business Operations (SBO) and focuses on clinical data validation, data quality control, query management, reconciliation, and clinical trial data review.
Candidates with 3–5 years of experience working with Medidata RAVE (EDC) or other Electronic Data Capture (EDC) systems, along with a scientific or Life Science-related degree and clinical trial data management experience, can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Sanofi |
| Job Role | Clinical Data Specialist |
| Location | Hyderabad, India |
| Job Type | Full Time |
| Experience | 3–5 Years |
| Qualification | Degree in a Scientific Discipline or Related Life Science Degree |
| Required Experience | Clinical Trial Data Management |
| EDC Platform | Medidata RAVE or Other EDC Systems |
| Job Requisition ID | R2873125 |
| Last Date to Apply | December 15, 2026 |
Position
Clinical Data Specialist
The selected candidate will be responsible for maintaining clinical data accuracy and integrity through data validation, quality control, reconciliation, and review activities.
Key Responsibilities
- Understand clinical data collection processes, including electronic Case Report Forms (eCRFs) in Medidata RAVE (EDC).
- Verify clinical data for consistency and identify discrepancies.
- Raise and manage queries to resolve clinical data issues.
- Perform User Acceptance Testing (UAT) for CRF changes and system updates.
- Document UAT findings and maintain issue logs.
- Create form entry and query metrics.
- Track eCRF review and backlog metrics.
- Review SAS-generated data listings, ad-hoc reports, and scanned reports for accuracy.
- Perform quality control of clinical data management activities.
- Conduct data reconciliation to maintain data integrity.
- Provide input to Data Review Guidelines (DRG) and Quality Management & Control Plans.
- Draft project-related documentation.
- Facilitate training for new team members and create test cases.
- Identify data validity problems and recommend data-driven quality improvement initiatives.
- Collaborate with internal stakeholders to support Registry study data management activities.
Eligibility and Qualifications
Candidates should meet the following requirements:
- 3–5 years of experience with Medidata RAVE (EDC) or other EDC systems.
- Degree in a scientific discipline or a related Life Science degree.
- Substantial experience in clinical trial data management.
- Previous experience in a similar role within the pharmaceutical or clinical research industry.
- Familiarity with regulatory requirements and clinical data management guidelines.
- High proficiency in written and spoken English.
Required Skills
Clinical Data Management Skills
- Medidata RAVE (EDC)
- Electronic Case Report Forms (eCRFs)
- Clinical Data Validation
- Clinical Data Review
- Query Management
- Data Reconciliation
- User Acceptance Testing (UAT)
- Clinical Data Quality Control
Technical Skills
- SQL
- SAS
- R
- Python
- Data Cleaning and Transformation
- Data Validation Techniques
- CDISC Standards
- HL7 Standards
- FDA and EMA Regulatory Guidelines
Professional Skills
- Analytical and problem-solving skills
- Attention to detail
- Written and verbal communication
- Documentation skills
- Organizational and project management skills
- Stakeholder management
- Confidentiality and teamwork
- Ability to manage multiple tasks and deadlines
About Sanofi Business Operations (SBO)
Sanofi Business Operations is an internal resource organization based in India that centralizes processes and activities supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions.
The organization focuses on developing internal expertise, reducing reliance on external service providers, and supporting global Medical, HEVA, and Commercial organizations.
