Clinical Data QC Reviewer
By Admin · Clinical Data Management
ROLE OVERVIEW
This Clinical Data QC Reviewer role at Sanofi Business Operations in Hyderabad sits at the heart of clinical data integrity for registry and real-world evidence studies. As Sanofi centralizes global medical, HEVA, and commercial support, this position ensures eCRF, EDC, and SAS listings meet rigorous quality control standards before they inform regulatory submissions, publications, or safety decisions. The reviewer will work with Medidata RAVE and cross-functional stakeholders to validate data, manage issues, perform UAT, and uphold GCP, FDA, EMA, and ICH expectations. It is a compelling opportunity for experienced clinical data professionals to deepen therapeutic and systems expertise, contribute to Sanofi’s Specialty Care, Vaccines, and General Medicines pipeline, and influence process improvements in a global, science-driven environment.
ROLE DEFINITION & RESPONSIBILITIES
- •Perform quality control reviews of clinical data deliverables against the Quality Control Plan, ensuring registry and RWE datasets meet accuracy, completeness, and consistency standards.
- •Validate electronic Case Report Form data in Medidata RAVE and other EDC systems, investigating discrepancies and confirming resolution with clinical teams.
- •Review SAS-generated data listings, ad-hoc reports, and scanned source documents to detect anomalies, outliers, and protocol deviations.
- •Execute user acceptance testing for CRF changes and system upgrades, documenting findings and verifying that issues are closed before release.
- •Maintain the study Issue Log, logging data queries, corrective actions, and resolution evidence in line with SOPs and regulatory requirements.
- •Complete required test cases and training per client and Sanofi standards to ensure ongoing data integrity and inspection readiness.
- •Track data management KPIs, identify risks and process efficiencies, and communicate status to internal stakeholders and global study teams.
- •Support continuous improvement initiatives, SOP updates, and audit preparation while collaborating across Medical, HEVA, and Commercial functions.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Life sciences degree such as B.Pharm, M.Pharm, PharmD, MSc, MBBS, or BSc in a scientific discipline.
- Minimum 8 years of hands-on clinical data management, validation, or QC experience within clinical research or pharmaceutical industry.
- Proven expertise using Medidata RAVE or comparable EDC systems for eCRF review, query management, and data validation.
- Strong working knowledge of ICH-GCP, FDA, EMA, and GMP guidelines, plus clinical trial and real-world evidence data processes.
- Demonstrated ability to review SAS listings, ad-hoc reports, and electronic source documents with meticulous attention to detail.
- Experience performing UAT, maintaining issue logs, and applying SOPs, validation protocols, and regulatory requirements.
- Excellent written and spoken English, with strong organizational skills for managing multiple deadlines and stakeholders.
PREFERRED QUALIFICATIONS
- •SQL, SAS, R, or Python for data review and analytics
- •CDISC SDTM/ADaM standards
- •Veeva Vault or clinical document management systems
- •Regulatory inspection and audit readiness
- •Vaccine, specialty care, or oncology therapeutic data experience
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
Sanofi is a global biopharmaceutical company dedicated to human health. It researches, develops, manufactures, and markets innovative therapeutic solutions with a focus on specialty care, vaccines, general medicines, and consumer healthcare products. The company aims to prevent and treat a wide range of diseases worldwide.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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