Job Title: Biomedical Data Stewardship Manager
Location: Remote
Job Summary: We are seeking a Biomedical Data Stewardship Manager for a remote opportunity supporting clinical trial data standards and SDTM specification development. Our team is looking for a detail-oriented professional who can help ensure data collection, analysis, and reporting standards are aligned with established guidance and repository processes.
Responsibilities:
- Develop mappings between data collection standards and SDTM standards within a metadata repository.
- Build and maintain guidance documents that support analysis and reporting standards.
- Ensure SDTM implementation decisions are compliant with CDISC guidance and industry and regulatory requirements.
- Support the management and continuous improvement of analysis and reporting standards and metadata.
Required:
- Doctoral degree and 4 years of clinical trials experience, or Master’s degree and 6 years of clinical trials experience, or Bachelor’s degree and 8 years of clinical trials experience.
- Proficient in CDISC SDTM modeling, CDISC IGs, TAUGs, and regulatory guidance documents.
- Experience with clinical trial support and SDTM specifications development.
- Strong communication, collaboration, organizational, and self-motivation skills.
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