Director Integrated Data Quality

Responsibilities:
- Define and lead the Integrated Data Review (IDR) strategy, including an operating model and governance framework across the portfolio.
- Ensure consistent execution and oversight of Data Review Plans (DRPs), proactively identifying data quality risks and critical issues.
- Define minimum requirements and create standardized IDR/DRP methodologies, templates, processes, and guidance for study teams.
- Oversee DRP execution through governance processes, KPIs, and quality metrics to drive consistency, effectiveness, standards adherence, and continuous improvement.
- Partner with Clinical Data Reporting to develop standardized libraries of IDR outputs (visualizations, listings, dashboards, patient profiles).
- Collaborate with Quantitative Innovation and Statistical Strategy (QISS) to translate Risk-Based Data Management (RBDM) into practical data review approaches and study requirements.
- Identify risks to data quality, integrity, and timelines; implement mitigation strategies.
- Drive continuous improvement/innovation in IDR methodologies and technologies using metrics, lessons learned, inspection observations, and evolving practices.
- Develop and maintain SOPs, work instructions, templates, and training materials using quality-by-design principles.
- Lead change management and training to ensure adoption; drive IDR adoption across clinical and external data domains.
- Liaise with internal/external collaborators for effective communication and cross-functional collaboration.

Qualifications:
- 12+ years in Clinical Data Management in biotech/pharma/health; 5+ years people management/leadership/mentoring.
- Expert knowledge of clinical data management and integrated data review principles, data quality management, and critical-to-quality concepts.
- Deep knowledge of regulatory/industry standards: ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, and global data privacy regulations.
- Working knowledge of RBDM; understanding of RBQM and its relationship to IDR and centralized monitoring.
- Demonstrated experience establishing and evolving IDR frameworks/governance/methodologies; identifying critical data and defining risk-based review strategies.
- Experience analyzing clinical/operational/external data to identify trends and quality issues.
- Experience developing/implementing/overseeing DRPs and governance processes.
- Knowledge of KPIs/quality metrics for IDR impact.
- Ability to solve complex problems; lead/influence in a matrix organization.

Application:
- Apply now.