Study Data Manager

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

·       Strong 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