Job Summary
A company is looking for a Biomedical Data Stewardship Manager to drive the design, implementation, and governance of standardized data collection practices across clinical programs.
Key Responsibilities
- Design and define standard, indication-level case report form (CRF) libraries and document implementation rules
- Provide expert consultation and hypercare support to study teams in applying CRF library content
- Monitor adoption and consistency of CRF standards, conducting audits and reviews to ensure alignment with study and regulatory needs
Required Qualifications
- Doctorate degree or equivalent experience in clinical settings
- Master's degree with 2 years, Bachelor's degree with 4 years, Associate's degree with 8 years, or High school diploma/GED with 10 years of clinical experience
- 5+ years of experience in data management, biostatistics, or clinical programming within the pharmaceutical or biotechnology industry
- Proven experience with CRF design and data standards governance
- Experience in data collection, analysis, and reporting within drug development and clinical trial processes
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