Associate Director, Clinical Data Management
Structure Therapeutics
13 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Reporting to the Senior Director of Clinical Data Management (CDM), the Associate Director (AD) oversees the strategic and operational aspects of data management for assigned clinical studies. Responsibilities include planning, implementing, and managing CDM CRO activities, including database/technology selection, vendor management, data collection, ensuring quality standards, and meeting timelines. Serves as primary DM contact partnering with Clinical Operations, Biostatistics, Clinical Development, and Regulatory Affairs to align data management with clinical development strategy and regulatory requirements.
Job Responsibilities
- Represent CDM in study meetings, providing updates on trials, challenges, and strategy.
- Supervise development, validation, and production release of clinical databases per Structure and CRO SOPs/working instructions; oversee and conduct sponsor acceptance testing.
- Develop/review DM documentation (e.g., CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, Data Transfer Specifications).
- Conduct regular data reviews to identify, document, and resolve key discrepancies before deliverables.
- Ensure internal study team oversight per the Data Quality Oversight Plan (DQOP); document observations in the cumulative Data Issue Tracker and confirm resolution.
- Support/lead SOP development, procedural documentation, and continuous process improvement; identify simplification/innovation and emerging enabling technologies.
Qualifications
- BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
- 10+ years clinical data management experience in pharmaceutical and/or CROs.
- Complex and international trial experience desired.
- Extensive experience with Medidata Platform modules.
Benefits
- Anticipated base pay range: $180K–$220K.
- Eligible for annual performance incentive bonus, new hire equity, and ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.
Application Instructions
- Apply through the official career page at BambooHR.
Reporting to the Senior Director of Clinical Data Management (CDM), the Associate Director (AD) oversees the strategic and operational aspects of data management for assigned clinical studies. Responsibilities include planning, implementing, and managing CDM CRO activities, including database/technology selection, vendor management, data collection, ensuring quality standards, and meeting timelines. Serves as primary DM contact partnering with Clinical Operations, Biostatistics, Clinical Development, and Regulatory Affairs to align data management with clinical development strategy and regulatory requirements.
Job Responsibilities
- Represent CDM in study meetings, providing updates on trials, challenges, and strategy.
- Supervise development, validation, and production release of clinical databases per Structure and CRO SOPs/working instructions; oversee and conduct sponsor acceptance testing.
- Develop/review DM documentation (e.g., CRFs, CRF completion guidelines, Data Management Plan, Edit Check Specification, Data Review Plan, Data Transfer Specifications).
- Conduct regular data reviews to identify, document, and resolve key discrepancies before deliverables.
- Ensure internal study team oversight per the Data Quality Oversight Plan (DQOP); document observations in the cumulative Data Issue Tracker and confirm resolution.
- Support/lead SOP development, procedural documentation, and continuous process improvement; identify simplification/innovation and emerging enabling technologies.
Qualifications
- BS/MS in Life Sciences, Informatics, Computer Sciences, or related fields.
- 10+ years clinical data management experience in pharmaceutical and/or CROs.
- Complex and international trial experience desired.
- Extensive experience with Medidata Platform modules.
Benefits
- Anticipated base pay range: $180K–$220K.
- Eligible for annual performance incentive bonus, new hire equity, and ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.
Application Instructions
- Apply through the official career page at BambooHR.