Associate Director, Data Validation Strategy
$157.2k - $256.6kRegeneron Pharmaceuticals, Inc.
Associate Director leading data validation strategy within Clinical Data Management at a pharmaceutical company. Will oversee integrated data review implementation, ensure clinical data quality and inspection readiness, and manage cross-functional collaboration with biostatistics and study teams.
Responsibilities
- Lead implementation and execution of Integrated Data Review strategy, operating model, and governance
- Oversee development and quality of Data Review Plans with issue tracking and escalation
- Partner with Biostatistics, Clinical Data Reporting, and study teams on risk-based data review
- Monitor performance through KPIs and quality metrics to drive continuous improvement
- Manage, mentor, and develop the Integrated Data Review and Quality team
Requirements
- Bachelor's degree in Life Sciences, Statistics, Computer Science, or related field
- 10+ years clinical data management experience in biotech, pharma, or healthcare
- 5+ years people, team, and project leadership experience
- Knowledge of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, RBDM/RBQM principles
- Experience with integrated data review, quality management, or centralized review processes
- Experience supporting inspection readiness activities
- Proficiency with data review tools, visualization, and analytics platforms
Compensation: $157,200–$256,600 annually
Vacancy posted 2 days ago
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