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# Associate Director, Data Validation Strategy

- **Company:** Regeneron
- **Location:** Warren, NJ, United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Clinical Data Management, Clinical Data Repository, Data Validation, Issue Tracking Systems, Information Technology, Performance Monitor, Data Management, GXP
- **Published:** October 6, 2026
- **Apply:** https://dejobs.org/x/x/E47F4B19F04C4A52B587F9701762B5B3/job/

## About the Role

* 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

## Description

* 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