Senior Data Standards Expert (all genders)
The businesses of Merck KGaA, Darmstadt, Germany · GB
3 days agoImpress employers and recruiters.
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About the Role
Shape and maintain clinical data standards and design high-quality electronic case report forms for global clinical studies. Lead complex study builds in electronic data capture systems, manage metadata and standards libraries, and ensure alignment with CDISC, CDASH and SDTM requirements. Oversee standards deliverables from external partners, support submission readiness, manage study-level standards exceptions, and apply quality-by-design principles. Mentor colleagues and drive improvements in standards governance, automation and emerging data formats.
Responsibilities
- Shape and maintain clinical data standards
- Design high-quality electronic case report forms for global clinical studies
- Lead complex study builds in electronic data capture systems
- Manage metadata and standards libraries
- Ensure alignment with CDISC, CDASH and SDTM requirements
- Oversee standards deliverables from external partners
- Support submission readiness
- Manage study-level standards exceptions
- Apply quality-by-design principles
- Mentor colleagues
- Drive improvements in standards governance, automation and emerging data formats
Requirements
- Advanced degree in life sciences, computer science or equivalent experience
- 6 - 8 years in clinical data standards, data management or eDC design
- Experience leading complex studies and cross-functional projects
- Knowledge of regulatory submissions and validation tools
Skills
- CDISC
- CDASH
- SDTM
- Metadata
- CRF design
- Clear communication
- Problem-solving
- Mentoring
Location
- Feltham, UK
Work Type
- On-site
- Hybrid
Experience Level
- Senior
Education Level
- Advanced degree in life sciences, computer science or equivalent experience
About the Company
- Colleagues across the globe innovate with science and technology to enrich people’s lives with solutions in Healthcare, Life Science, and Electronics.
- The company dreams big and is passionate about caring for its rich mix of people, customers, patients, and planet.
- The company is committed to creating access and opportunities for all to develop and grow at their own pace.
- The company aims to build a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress.