India's DMPLOI - Jobs & Networking App
Company: Sanofi
Job Title: Clinical Data QC Reviewer
Location: Hyderabad, Telangana, India
Department: Clinical Data Management / Quality Control
Industry: Pharmaceutical / Clinical Research
Experience Required: 8+ Years
Qualification: Degree in a scientific discipline or a related life sciences field, with substantial clinical trial data management experience
Application Mode: Online
Job Description
Sanofi is inviting applications for the position of Clinical Data QC Reviewer at its Sanofi Business Operations (SBO) facility in Hyderabad, Telangana.
Sanofi Business Operations supports global business functions across Specialty Care, Vaccines, General Medicines, Consumer Healthcare, Contract Manufacturing Operations, and Research & Development. The organization focuses on operational excellence, internal expertise, and high-quality delivery of business processes.
The selected candidate will be responsible for reviewing clinical data, conducting quality control activities, validating registry study data, and ensuring accuracy, completeness, and compliance with applicable clinical research standards.
Key Responsibilities
- Perform quality control reviews of deliverables according to the Quality Control Plan (QCP).
- Conduct clinical registry data validation to ensure accuracy and completeness.
- Work with electronic Case Report Forms (eCRFs) and Medidata RAVE Electronic Data Capture (EDC) systems.
- Review SAS-generated data listings, ad hoc reports, and scanned documents for consistency and accuracy.
- Perform User Acceptance Testing (UAT) for CRF changes and system updates.
- Document testing findings, track data issues, and ensure appropriate resolution.
- Maintain issue logs and complete test cases according to client training requirements.
- Monitor project databases, data management deliverables, and key performance indicators (KPIs).
- Identify potential risks, recommend process improvements, and support operational excellence.
- Collaborate with internal stakeholders to ensure compliance with approved processes and clinical data management standards.
Eligibility Criteria
Experience
- Minimum 8+ years of experience with Medidata RAVE or other Electronic Data Capture (EDC) systems.
- Hands-on experience in clinical data management, quality control, quality assurance, or clinical data validation.
- Experience with clinical trial and/or real-world evidence (RWE) data management.
Technical Skills
- Knowledge of clinical data validation and quality control processes.
- Familiarity with SAS, SQL, R, Python, or other data management and analysis tools.
- Understanding of validation protocols, Standard Operating Procedures (SOPs), and regulatory requirements.
- Knowledge of Good Clinical Practice (GCP), relevant GMP standards, and FDA, EMA, and ICH guidelines.
- Ability to identify discrepancies, troubleshoot data issues, and implement corrective actions.
Soft Skills
- Excellent written and verbal communication skills in English.
- Strong analytical skills and attention to detail.
- Good organizational and project management abilities.
- Ability to manage multiple tasks, meet deadlines, and coordinate with stakeholders.
Educational Qualification
A degree in a scientific discipline or a related life sciences field, supported by substantial experience in clinical trial data management.
How to Apply
Interested and eligible candidates can review the complete job description and submit their applications through the official LinkedIn job listing.
Or
Important: This position requires 8+ years of relevant EDC experience. Candidates should review the complete eligibility criteria before applying.
