Manager, Biomedical Data Stewardship
Tasks
- Align governed standards with protocol authoring practices
- Collaborate with global BMDS leadership
- Develop and maintain MDR QC reports
- Develop implementation guides and controlled documents
- Ensure adherence to policies and SOPs
- Execute biomedical data stewardship activities
- Manage metadata repository entry
- Perform impact assessments and change control documentation
- Plan and execute library updates across studies
- Provide data standards expertise to stakeholders
- Provide protocol standards subject matter expertise
- Review protocols for library compliance
- Support automation for efficiency and compliance
- Support structured authoring and library implementation
- Validate MDR entry outputs and remediate errors
Perks/Benefits
Skills/Tech-stack
Change Control | Clinical data | Clinical data standards | Data Standards | Data standards governance | Documentation Development | Impact analysis | Inspection Readiness | Medical writing | Metadata Management | Metadata repository | Process Automation | Process Improvement | Project Planning | Protocol Authoring | Quality Control | Regulatory writing | SAP | SDTM | Stakeholder management | Standards Governance | Structured Templates | Structured authoring | Version control
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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