Full Job Description
Associate Director, Data Validation Strategy
Lead the implementation and execution of the Integrated Data Review (IDR) strategy, operating model, standards, and governance
• Oversee the development, execution, and quality of Data Review Plans (DRPs), including issue tracking, escalation, and resolution
• Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams delivering risk-based data review aligned with critical-to-quality factors
• Monitor performance through KPIs and quality metrics to identify trends and drive continuous improvement
• Support the development of SOPs, work instructions, templates, and training materials for IDR activities
• Lead training, coaching, and change management to drive adoption of IDR across clinical and external data domains
• Drive innovation, automation, and AI-enabled analytics initiatives
• Manage, mentor, and develop the Integrated Data Review and Quality team
This role requires
• Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field
• 10+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or healthcare industry and 5+ years of people, team, and project leadership experience
• Experience implementing integrated data review, quality management, risk-based data management, or centralized review processes
• Strong working knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and RBDM/RBQM principles
• Experience supporting inspection readiness activities
• Experience with data review tools, visualization, and analytics for proactive issue detection
Location: Warren, NJ, Armonk or Tarrytown, NY
Work model: Primarily on-site with hybrid flexibility
Travel percentage: Up to 25%
Salary Range (annually)
$157,200.00 - $256,600.00