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# Associate Director, Data Validation Strategy

- **Company:** Regeneron
- **Location:** Armonk, NY, United States
- **Experience:** Expert
- **Salary:** $157,200.0 - $256,600.0
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Clinical Data Management, Clinical Data Repository, Issue Tracking Systems, Information Technology, Performance Monitor, Data Management, GXP
- **Published:** October 8, 2026
- **Apply:** https://www.dice.com/job-detail/848d96f9-9aba-4549-9a9a-cb164f50e048

## 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