Job Description: Data Validation Team Member
About the Team
Sanofi Business Operations (SBO) is an internal resource organization based in India. It supports Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions globally.
SBO reduces reliance on external service providers, builds internal expertise, and leverages a diverse talent pool to deliver strategic and tactical support across Medical, HEVA, and Commercial organizations.
Main Responsibilities
Core Activities
System & Data Collection: Work with electronic Case Report Forms (eCRFs) in Medidata RAVE (EDC).
Data Verification: Check data for accuracy, consistency, and discrepancies.
Query Management: Raise, manage, and resolve queries for data issues.
User Acceptance Testing (UAT): Conduct UAT for CRF changes and system updates, document results.
Issue Log Management: Maintain and update issue logs with findings and resolutions.
Metrics:
Generate form entry and query metrics.
Track eCRF review progress and backlog.
Data Review: Validate data listings produced in SAS, ad-hoc reports, and scanned reports.
Quality Control: Ensure QC checks are implemented across all assigned activities.
Reconciliation: Perform data reconciliation to maintain data integrity.
Guidelines & Documentation:
Contribute to Data Review Guidelines (DRG) and Quality Management & Control Plans.
Draft project documents as needed.
Training: Train new team members, create test cases, and facilitate knowledge transfer.
People & Performance
Stakeholder Alignment: Collaborate with internal stakeholders to prioritize registry study data management activities.
Support Team Initiatives: Recommend and implement process improvements.
Ensure Data Accuracy: Identify sources of data issues and implement data-driven quality improvement processes.
Compliance & Operational Excellence: Maintain compliance with regulatory standards and Sanofi processes.
Stakeholder Collaboration
Commit to Customers: Understand and meet expectations of internal/external stakeholders.
Cooperate Transversally: Work with peers and cross-functional partners to ensure efficiency and effectiveness.
About You
Experience
3+ years’ experience with Medidata RAVE (EDC) and SAS.
Previous experience in clinical research or pharmaceutical industry.
Familiarity with regulatory requirements for clinical data management.
Soft Skills
Strong written and oral communication skills.
Organizational and project management abilities.
Effective stakeholder management.
Ability to maintain confidentiality of sensitive data.
Technical Skills
Proficiency in data management tools: SQL, SAS, R, Python.
Knowledge of data cleaning, transformation, and validation.
Understanding of clinical data standards (CDISC, HL7).
Awareness of regulatory guidelines (FDA, EMA).
Education
Degree in Life Sciences or a related scientific discipline.
Strong experience in clinical trial data management.
Ability to handle multiple tasks with attention to detail.
Languages
High proficiency in spoken and written English.
Why Join Us?
At Sanofi, progress begins with people. We bring together diverse talents to push boundaries and deliver extraordinary science. Here, your growth matters as much as the work you do.
Equal opportunities employer across all backgrounds.
Commitment to Diversity, Equity, and Inclusion (DEI).
Watch “One Day at Sanofi” and explore DEI initiatives at sanofi.com.
Pursue Progress. Discover Extraordinary.
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