Strategic Lead, Data Validation & Integrated Data Review

Regeneron Pharmaceuticals, Inc.

New Jersey

Hybrid

USD 157,000 - 257,000

Full time

2 days ago

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Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director, Data Validation Strategy to lead IDR strategy within Clinical Data Management.

You will drive data review standards and governance, partnering with Biostatistics, QISS, Clinical Data Reporting, and study teams to ensure high-quality, inspection-ready data. The role focuses on defining DRPs, tracking issues, and guiding a team through training and change management, while pushing innovation and AI-enabled analytics to improve data

Qualifications

Bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field.
10+ years of Clinical Data Management experience with leadership experience.
Experience implementing integrated data review and quality management.

Responsibilities

Lead the implementation and execution of the Integrated Data Review (IDR) strategy and governance.
Oversee the development, execution, and quality of Data Review Plans (DRPs) with issue tracking and resolution.
Partner with Biostatistics, QISS, Clinical Data Reporting, and study teams on risk-based data review.
Monitor KPIs and quality metrics to identify trends and drive improvement.
Develop SOPs, work instructions, templates, and training materials for IDR activities.
Lead training, coaching, and change management to drive IDR adoption.
Drive innovation, automation, and AI-enabled analytics initiatives.
Manage, mentor, and develop the Integrated Data Review and Quality team.