Director Integrated Data Quality

Role: Lead the development and execution of integrated data review (IDR) strategies for clinical programs to ensure high-quality, inspection-ready data. Responsibilities: establish scalable frameworks, oversee Data Review Plans (DRPs), develop standardized methodologies, and implement governance processes; collaborate with Data Reporting and Quantitative teams to develop data visualization tools; identify data quality risks proactively and drive continuous process improvements; lead change management, training, and adoption of IDR practices across teams; and maintain compliance with industry standards. Requirements: 12+ years in Clinical Data Management within biotech/pharma, with 5+ years in leadership; expert knowledge of data management principles, integrated review strategies, GxP, ICH guidelines, 21 CFR Part 11, and global data privacy; experience establishing governance models, risk-based review strategies, and centralized monitoring; proven ability to lead cross-functional initiatives within matrix organizations. HighValue: extensive clinical data management expertise, integrated data review frameworks, risk management, GxP compliance, global regulatory standards, and leadership across clinical development stages. WorkSetup: on-site 4 days/week in Warren NJ, Armonk NY, or Tarrytown NY, with approximately 10% travel.