Director Integrated Data Quality
Regeneron · Warren +2 more
QualityFull-time$183k–$305kCompany career page
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What they're looking for
- 12+ years clinical data management in biotech, pharmaceutical, or health industry
- 5+ years people management, leadership, and mentoring experience
- Expert knowledge of clinical data management principles, processes, and technologies
- Expert knowledge of integrated data review, data quality management, and critical-to-quality concepts
- Deep understanding of regulatory requirements including ICH E6, ICH E8, GxP, 21 CFR Part 11
- Working knowledge of Risk-Based Data Management and Risk-Based Quality Management principles
- Demonstrated experience establishing integrated data review frameworks and governance models
What you'll be doing
- Define and lead integrated data review strategy including operating model and governance framework
- Oversee execution of Data Review Plans and proactively identify data quality risks across programs
- Develop standardized data review methodologies, templates, and guidance for consistent execution
- Partner with Clinical Data Reporting and QISS teams to translate risk methodologies into practical approaches
- Drive continuous improvement in integrated data review methodologies through metrics and industry practices analysis
Privacy & handoff
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