Director, Clinical Data Management
Stoke Therapeutics · Bedford, MA
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Role summary
Stoke Therapeutics seeks a Director of Clinical Data Management to lead data management operations for clinical development programs using RNA medicine. The role oversees internal teams and CRO vendors, manages budgets, ensures regulatory compliance, and implements quality-by-design principles across the clinical portfolio.
What they're looking for
- Experience leading clinical data management teams and CRO oversight
- Knowledge of ICH E6(R3) and risk-based data governance approaches
- Expertise in electronic data capture (eCRF) design and validation
- Experience with data management planning and clinical trial databases
- Familiarity with regulatory inspection readiness and quality compliance
- Strong project and budget management capabilities
What you'll be doing
- Lead data management activities and oversee CRO vendor performance for clinical programs
- Manage data management team and balance resources across current and future organizational needs
- Develop and maintain Data Management Plans aligned with study design and regulatory requirements
- Review clinical documents, eCRF specifications, edit rules, and data validation protocols
- Coordinate user acceptance testing for electronic systems and maintain regulatory compliance documentation
Privacy & handoff
This role links to Stoke Therapeutics's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.