Sanofi Business Operations (SBO) is hiring for Clinical Data Specialist and Clinical Data QC Reviewer positions in Hyderabad. These full-time roles focus on clinical data management, data validation, quality control, electronic data capture (EDC), UAT, data review, and maintaining clinical data integrity.
Job Details
| Details | Information |
|---|---|
| Company | Sanofi |
| Organization | Sanofi Business Operations (SBO) |
| Location | Hyderabad |
| Job Type | Full Time |
| Positions | Clinical Data Specialist; Clinical Data QC Reviewer |
| Clinical Data Specialist Experience | 3–5 years |
| Clinical Data QC Reviewer Experience | 8+ years |
| Application Deadline | December 15, 2026 |
| Job Requisition ID – Clinical Data Specialist | R2873125 |
| Job Requisition ID – Clinical Data QC Reviewer | R2873123 |
Positions
1. Clinical Data Specialist
The Clinical Data Specialist will support clinical data quality through data verification, query management, UAT, reconciliation, quality control, metrics tracking, and review of clinical data and reports.
2. Clinical Data QC Reviewer
The Clinical Data QC Reviewer will perform quality control and data validation activities for registry clinical data, review deliverables and data listings, conduct UAT, manage issue logs, and complete test cases to support data integrity.
Responsibilities
Clinical Data Specialist
- Understand system and data collection processes, including eCRFs in the Medidata RAVE EDC application.
- Verify data for consistency and identify discrepancies.
- Raise and manage queries to resolve data issues.
- Perform 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 data listings, ad-hoc reports, and scanned reports for accuracy.
- Perform quality control of activities within scope.
- Perform data reconciliation to ensure data integrity.
- Provide input to Data Review Guidelines and Quality Management & Control Plan.
- Draft project documents on an ad-hoc basis.
- Facilitate training for new team members and create test cases.
- Support process improvement initiatives and stakeholder collaboration.
Clinical Data QC Reviewer
- Perform quality control reviews of deliverables according to the Quality Control Plan.
- Conduct data validation activities on registry clinical data.
- Understand eCRFs and data collection processes in Medidata RAVE EDC.
- Review SAS data listings, ad-hoc reports, and scanned reports.
- Perform UAT for CRF changes and system updates.
- Document UAT findings and ensure issues are resolved.
- Update issue logs with data issues and resolutions.
- Complete test cases according to client training requirements.
- Maintain the project database.
- Conduct critical analyses of registry study data management objectives and deliverables.
- Track relevant data management KPIs.
- Identify potential risks and possible efficiencies for stakeholders.
- Support compliance readiness and operational excellence.
Eligibility & Qualifications
Clinical Data Specialist
Candidates should have:
- 3–5 years of experience with Medidata RAVE or other EDC systems.
- A degree in a scientific discipline or related life science discipline.
- Previous experience in a similar role within the pharmaceutical or clinical research industry.
- Familiarity with regulatory requirements and guidelines for clinical data management.
- Experience managing multiple tasks and deadlines.
- Strong attention to detail and analytical skills.
Clinical Data QC Reviewer
Candidates should have:
- 8+ years of experience with Medidata RAVE or other EDC systems.
- A degree in a scientific discipline or related life science discipline.
- Experience in quality control, quality assurance, or data validation within the clinical research or pharmaceutical industry.
- Hands-on experience with clinical data management and validation processes.
- Familiarity with FDA, EMA, and ICH guidelines.
- Knowledge of GCP and GMP standards.
- Experience managing multiple tasks and deadlines.
- Strong attention to detail and analytical skills.
Required Skills
Clinical Data Specialist
- Medidata RAVE / EDC
- Clinical data verification
- Query management
- Data reconciliation
- UAT
- Data validation
- Quality control
- SAS data listings
- SQL, SAS, R, or Python
- CDISC
- HL7
- Clinical data cleaning and transformation
- Regulatory requirements and guidelines
- FDA and EMA requirements
- Communication and documentation
- Stakeholder management
Clinical Data QC Reviewer
- Medidata RAVE / EDC
- Clinical data management
- Data validation
- Quality control
- Quality assurance
- UAT
- SAS, SQL, R, or Python
- Data troubleshooting
- Corrective actions
- Validation protocols
- SOPs
- Clinical trial and/or RWE data management
- FDA, EMA, and ICH guidelines
- GCP and GMP
- Clinical data quality and integrity