**_Job Duties and Responsibilities:_** The Study Data Manager (SDM) will be responsible for leading and overseeing all data management activities for one or more of the Sanofi Rare Disease Registries (e.g., Pompe Registry, Gaucher Registry). The SDM ensures the integrity and quality of the Registry data for regulatory requirements, scientific publications, patient care requests, and Registry data reports. This role serves as a key partner across cross-functional Registry teams and contributes to the continuous improvement of Registry data management practices at Sanofi. Key responsibilities include: · Contribute to data management activities as a study data manager in support of Sanofi Global Rare Disease Registries · Serve as the primary data management point of contact for cross-functional Registry teams, including Global Medical, Site Operations, and Statistical Programming · Develop and maintain key data management documents including the Data Management Plan (DMP), Data Review Guidelines (DRGs), and eCRF Completion Guidelines (eCCGs) · Develop and design case report forms (CRFs) in collaboration with the Registry teams · Develop training plans, conduct training, and provide guidance to internal Registry Data Management and Site Operations staff · Oversee data review and cleaning activities, including query management and discrepancy resolution · Oversee quality control of data review and query management activities being performed by Sanofi Hub data validation team as defined in the Data Validation Quality Control Plan · Monitor and report on data quality metrics,



proactively identifying and resolving issues · Ensure adherence of data review per the Registry Data Review Guidelines · Generate data listings and work with Registry Programming team to develop SAS checks to assist manual data review · Collaborate with the Registry Site Operations team on Registry data entry questions and management of patient administration (e.g., patient transfers, potential duplicate patients) · Support Registry CRF changes and Rave study build updates by managing technical requirements and performing user acceptance testing (UAT) · Ensure proper documentation and archiving of all data management study files · Contribute to the development and improvement of data management standards, processes, and tools **_Required Qualifications_** · Bachelor's degree or higher in life sciences, health informatics, or a related field · Minimum 8-10 years of clinical data management experience in the pharmaceutical/biotech industry, preferably on the sponsor side · Solid expertise as a Study clinical data manager, leading all data management aspects of a clinical study from start to finish · Proficiency with EDC systems, preferably Medidata Rave · Strong knowledge of CDISC standards (CDASH, SDTM) · Proficiency with Microsoft Office products, especially Excel · Proficiency with reporting/metrics tools (e.g., Business Objects, Power BI) · Excellent communication skills with proficiency in oral and written English language · Strong organizational and problem-solving skills · Ability to work independently and as part of a global, multi-disciplinary team **_Preferred Qualifications:_** · Experience with real-world data or observational studies - Registry experience a plus · Experience in rare diseases · Experience with Rave study build updates and user acceptance testing · Prior experience mentoring or leading junior team members **Pursue** **_progress_** **,



discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t;=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! We are an R&D; driven, AI-powered biopharma company committed to improving people's lives and creating compelling growth. Our team is guided by one purpose: we chase the miracles of science to improve people's lives. We want to build a healthier, more resilient world, and turn the impossible into the possible by discovering, developing, and delivering medicines and vaccines for millions of people around the world. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) Start a career that makes a difference. Reinvention is in our DNA. It's what drove our evolution from a small French enterprise to one of the world's leading biopharma companies. Whether it's using AI to shorten drug-discovery times or building trust in healthcare, you could be helping our teams make life better for patients, partners, and communities. This is where you grow your career. We open the door for you to explore new opportunities, push your limits, and connect with people who are driven by a shared purpose: we chase the miracles of science to improve people's lives.

📌 Study Data Manager (Hyderabad)
🏢 Sanofi Group
📍 Hyderabad