Senior Manager, Clinical Data Management
Structure Therapeutics
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Reporting to the Director, Clinical Data Management (CDM), Senior Manager (SM) will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeline of clinical data across multiple Phase I studies. Provide strategic oversight to the CRO CDM team and serve as primary DM contact with cross-functional teams (Clinical Operations, Biostatistics, Clinical Development, Regulatory Affairs) to align data management with clinical strategy and regulatory requirements.
Job Responsibilities
- Oversee the design, build, and validation of clinical databases using Medidata Rave EDC.
- Contribute to development/review of DM documentation including CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, and Data Transfer Specifications.
- Conduct regular data reviews to identify, document, and resolve key data discrepancies prior to deliverables.
- Ensure internal study-team oversight per each study’s Data Quality Oversight Plan (DQOP); document observations in the cumulative Data Issue Tracker and confirm resolution.
- Represent CDM in internal and external meetings, providing expert guidance on data-related matters.
Qualifications
- Education: BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
- Experience: 8+ years of clinical data management experience in pharmaceutical/biotech and/or CROs.
- Extensive experience with different modules on the Medidata platform.
Benefits (as stated)
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
- Apply via the official career page at BambooHR.
Reporting to the Director, Clinical Data Management (CDM), Senior Manager (SM) will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeline of clinical data across multiple Phase I studies. Provide strategic oversight to the CRO CDM team and serve as primary DM contact with cross-functional teams (Clinical Operations, Biostatistics, Clinical Development, Regulatory Affairs) to align data management with clinical strategy and regulatory requirements.
Job Responsibilities
- Oversee the design, build, and validation of clinical databases using Medidata Rave EDC.
- Contribute to development/review of DM documentation including CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, and Data Transfer Specifications.
- Conduct regular data reviews to identify, document, and resolve key data discrepancies prior to deliverables.
- Ensure internal study-team oversight per each study’s Data Quality Oversight Plan (DQOP); document observations in the cumulative Data Issue Tracker and confirm resolution.
- Represent CDM in internal and external meetings, providing expert guidance on data-related matters.
Qualifications
- Education: BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
- Experience: 8+ years of clinical data management experience in pharmaceutical/biotech and/or CROs.
- Extensive experience with different modules on the Medidata platform.
Benefits (as stated)
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Application Instructions
- Apply via the official career page at BambooHR.