Head of Data Management | Head of Data Management (M/W/D)
S4G Talent Solutions GmbH
Job Summary
This critical leadership role involves leading the Clinical Data Management team for an international Contract Research Organization (CRO) specializing in metabolic diseases and diabetes. The Head of Data Management will be responsible for the end-to-end management of data processes, ensuring top-tier quality, speed, and compliance with regulatory standards (GCP/ICH/CDISC). Day-to-day activities include defining the operating model, providing disciplinary and technical leadership, developing and maintaining SOPs, optimizing DM processes (eCRF design, Query Management), and managing the EDC landscape. A key focus is driving digital transformation, including the implementation of new technologies like AI, and ensuring audit/inspection readiness. The ideal candidate possesses a background in Life Sciences or Informatics, extensive experience in clinical data management (ideally Phase I/II), proven leadership skills, and expertise in CDISC/SDTM standards and EDC systems, driving the company's expansion and increased capacity needs.
Required Skills
Education
Completed degree in Life Sciences, Informatics, Medical Documentation, or Economics with a strong Health/Data focus
Experience
- Several years of professional experience in clinical data management
- Experience in Phase I/II clinical trials
- Experience in a regulated environment (GCP/ICH)
- Demonstrable leadership experience focused on team development
- Proficiency in Change Management, agile methods, and digital process design
- Practical experience with EDC systems and CDISC/SDTM
Languages
Additional
- Routine in an international setting; Must be based near Neuss, Germany (location of the role); Must report directly to the CCO.