Study Data Manager

Responsibilities

• Lead and oversee all data management activities for Sanofi Global Rare Disease Registries
• Serve as the primary data management point of contact for cross-functional teams including Global Medical, Site Operations, and Statistical Programming
• Develop and maintain key data management documents such as the Data Management Plan (DMP), Data Review Guidelines (DRGs), and eCRF Completion Guidelines (eCCGs)
• Design case report forms (CRFs) in collaboration with Registry teams
• Oversee data review and cleaning activities, including query management and discrepancy resolution
• Monitor and report on data quality metrics to proactively identify and resolve issues
• Support Registry CRF changes and Rave study build updates through technical requirement management and User Acceptance Testing (UAT)
• Ensure proper documentation and archiving of all data management study files

Requirements

• Bachelor’s degree or higher in life sciences, health informatics, or a related field
• 8-10 years of clinical data management experience in the pharmaceutical/biotech industry
• Strong expertise in leading all data management aspects of a clinical study from start to finish
• Proficiency with EDC systems, specifically Medidata Rave
• Strong knowledge of CDISC standards (CDASH, SDTM)
• Proficiency with Microsoft Office products, especially Excel
• Proficiency with reporting and metrics tools such as Power BI or Business Objects
• Excellent oral and written English communication skills

Preferred Qualifications

• Experience with real-world data or observational studies (Registry experience is a plus)
• Experience working within the rare disease therapeutic area
• Experience with Rave study build updates and user acceptance testing (UAT)
• Prior experience mentoring or leading junior team members

About the Company

Sanofi is a global healthcare leader where groundbreaking science shapes the future of care. We are dedicated to delivering transformative treatments for patients worldwide, ranging from established medicines to pioneering breakthroughs in immunology and chronic disease care. At Sanofi, we embrace AI and digital tools to accelerate innovation and expand access to healthcare globally.