Apogee Therapeutics is a clinical-stage biotechnology company seeking an Associate Director, Data Management to manage the direction, planning, execution, and interpretation of data management activities for clinical trials.
Requirements
- Provide operational leadership to the direction, design, planning, execution, collection, and handling of all clinical data
- Coordinate and participate in the review of clinical data
- Ensure the quality of clinical data within EDC systems
- Work closely with CROs to prepare and ensure proper development and execution of data management activities
- Review protocols to ensure database feasibility
- Provide effective oversight of all CRO data management related deliverables
- Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools
- Work collaboratively with various functions to deliver high quality data
- Responsible for documentation and archival standards for Data Management deliverables
- Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission
- Responsible for development, maintenance, and governance of CDM standards
Benefits
- Market competitive compensation and benefits package
- Performance bonus
- Equity grant opportunities
- Health, welfare, and retirement benefits
- Competitive time off, including three weeks PTO and two one-week company-wide shutdowns a year
- Dedicated paid sick leave