Early Development Global Study Data Leader

Overview Early Development Global Study Data Leader – Sanofi Join to apply for the Early Development Global Study Data Leader role at Sanofi. Location: Gent, Belgium | Work arrangement: hybrid, minimum 3 days/week in the office. About the Job The Global Study Data Leader is responsible for leading the end-to-end data management activities and associated quality deliverables for clinical trials including study set-up, conduct, and close-out, complying with GCP and applicable regulatory guidance. Provide comprehensive data management expertise and support to team members. Coordinate cross-functional teams globally to ensure the flawless conduct of a clinical trial. Ensure activities are completed according to agreed standards and timelines and serve as the Data Management representative in the study team. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives. Main Responsibilities Contribute to the implementation of department initiatives and objectives and coordinate cross-functional working groups. Implement and oversee processes, working with the internal team and Clinical Data Delivery Leader; continually evaluate processes and applications for improvements. Oversee vendor activities to identify risks and ensure activities are completed according to the SOW, regulations, and quality expectations. Implement quality control strategies and remediation as necessary. Ensure that all external data loading and integration activities (Incl. eCOA, IRT, central labs) are well established and that data is loaded per study timelines, including transfer specifications and reconciliations. Ensure data quality by conducting and/or overseeing data management activities including validation, data review, and safety data reconciliation. Ensure efficient implementation and follow-up of data management activities for outsourced trials. Develop and drive retro planning for important deliverables such as interim analyses, DMCs, partial and final database locks; provide clear updates and escalations to study teams and management. Lead the team through DM lock recommendations and rationales, including implementation of Data Point Lock Strategy. Drive inspection readiness by ensuring ongoing TMF completion for all DM-related documents (including documents from third parties where applicable). Education & Experience Bachelor’s degree or higher (preferably in life sciences or health-related field) and 8–10 years of Clinical Data Management experience in the pharmaceutical industry, or equivalent. A formal degree may be substituted with equivalent experience. Experience 5+ years of experience in Clinical Data Management in the pharmaceutical industry (or equivalent) is required. 2+ years of project management experience in Data Management is required. CDMS experience and understanding of database/programming concepts. Understanding of industry standards and regulatory guidelines (e.g., CDISC SDTM, MedDRA) and GCP practices related to Data Management. Vendor management and solid knowledge of the clinical trial development process. Understanding of risk-based methodologies and regulations. Experience using data visualization tools (e.g., Spotfire, J-Review, Cluepoints preferred). Core Knowledge, Competencies & Skills Intermediate: Strong Data Management expertise; solid knowledge of the clinical trial development process, regulatory guidelines, GCP, and related practices. CDMS/EDC experience and understanding of database development concepts. Strong collaboration, interpersonal and communication skills; proactive risk identification and escalation. Advanced: Project management skills; ability to think critically and solve multidimensional problems; mentor and coach Data Managers. Leadership & Expertise Strong experience in data management outsourcing and vendor management; participate in BID defense meetings as needed. Ability to present data management topics at CSO level or relevant conferences; mentor for data management support; lead cultural and structural improvements within the organization. Why choose us? Make your work count by supporting a company delivering life-changing treatments to patients and communities. Help simplify, scale, and modernize how a global biopharma delivers smarter, faster, and more sustainable outcomes. Support cross-functional teams by building better systems, shaping bold strategies, and enabling innovation at speed. Collaborate with leaders across borders and functions to turn complex challenges into real-world solutions. Advance your career through stretch roles, cross-functional moves, and development opportunities. Thrive in inclusive, high-performing teams where every role matters and every voice helps shape what’s next. Be part of a dynamic, multidisciplinary environment where your experience is valued. Other Seniority level: Mid-Senior level Employment type: Full-time Job function: Information Technology Industries: Pharmaceutical Manufacturing Note: This listing is for the Early Development Global Study Data Leader role at Sanofi and reflects current openings and postings. #J-18808-Ljbffr