Manager, Data Management

Job title: Manager, Data Management

About the Role Preferrably based in France with Munich as an alternative location. The Manager, Data Management is accountable for end-to-end delivery of clinical data management services for assigned studies, collaborating with study teams, CROs, external vendors, and partners to ensure high quality deliverables are on time to support drug development processes and global submissions. The role also partners with internal and external stakeholders to optimize DM technology, processes, and standards and may manage multiple studies concurrently while overseeing DM resources.

What You'll Do

• Establish Data Management deliverables and expectations at the study level; proactively identify and manage risks to data quality and timelines; escalate issues to the DM program lead.
• Manage DM resources for assigned studies; provide FSP/Vendor oversight for end-to-end Data Management activities.
• Act as a core member of the Study Team and collaborate with other line functions to achieve study deliverables; serve as a DM ambassador and SME; participate in audits and inspections as the DM SME for the study.
• Lead project management for DM activities across the study lifecycle (startup, conduct, closeout); ensure proper planning of DM resources and ensure compliance with protocol, Policies, SOPs, external/internal standards, GCPs, applicable regulatory requirements, and other guidelines.
• Ensure Data Management deliverables meet/exceed study team quality and timeline expectations; file/archive DM documentation per Daiichi Sankyo and regulatory requirements.
• Study Start-Up: participate in start-up meetings to determine data requirements; coordinate with DM staff and vendors on responsibilities and timelines; review and approve DM start-up documents (CRF, eCRF guidelines, edit checks, DM Plan, Data Review Plan, UAT Plan, etc.).
• Review and approve study-specific DM documentation and participate in cross-functional reviews of data collection forms/methods and data cleaning tools for consistency with program standards.
• Study Conduct: oversee data review and quality checks; manage updates to DM documentation and deliverables; communicate changes to DM resources and vendors; evaluate impact of study changes and ensure appropriate approvals.
• Authorize release of databases/EDC systems into production.
• Maintain alignment with study timelines and quality expectations through collaboration with internal and external stakeholders (clinical data cleaning, data transfers, SAE reconciliation, local lab data processing, medical coding, etc.).

What We're Looking For

• Strong working knowledge of clinical data management processes, EDC/related applications, industry standards, and skills in working with data from CROs and external vendors.
• Excellent verbal/written communication, analytical, organizational, and interpersonal abilities; capable of working with people at different levels, disciplines, and cultures.
• Knowledge of clinical operations, biostatistics, and applicable regulatory requirements.
• Experience across multiple phases within the medical device and/or pharmaceutical industry in one or more complex disease areas.
• Proven experience in continuous improvement, project management, change management, and risk management.
• Ability to manage multiple studies concurrently and lead DM resources effectively.