Director, Clinical Data Management Job at Stoke Therapeutics, Bedford, MA

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  • Stoke Therapeutics
  • Bedford, MA

Job Description

Stoke Therapeutics seeks a Director of Clinical Data Management to lead data management operations across clinical development programs. The role oversees internal and CRO-managed data activities, manages a data management team, and ensures quality and compliance throughout the study lifecycle.

Responsibilities

  • 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

Requirements

  • 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

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