Biomedical Data Stewardship Manager

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
• Monitor adoption and consistency of CRF standards, conducting audits and reviews
• Provide expert consultation and hypercare support to study teams in applying CRF library content

Required Qualifications

• Doctorate degree, or a Master's degree with 2 years of clinical experience, or a Bachelor's degree with 4 years of clinical experience, or an Associate's degree with 8 years of clinical experience, or a high school diploma/GED with 10 years of clinical experience
• Degree in a related field such as statistics, biostatistics, life sciences, programming, computer science, or business administration is preferred
• 5+ years of cumulative experience in data management, biostatistics, or clinical programming within the pharmaceutical or biotechnology industry
• 3+ years of experience in a global, matrixed organization
• Proven experience with CRF design and data standards governance