Regeneron
Website:
regeneron.com
Job details:
Position Summary
Regeneron is seeking a Manager, Integrated Data Review (IDR) & Quality to support and help build our Integrated Data Review capability in India. This role will provide both people leadership and hands-on technical expertise in reviewing clinical trial data, identifying data quality risks, driving issue resolution, and ensuring high-quality, inspection-ready data across Regeneron's clinical development portfolio.
The successful candidate will partner closely with study teams and global stakeholders to execute data review strategies, facilitate cross-functional review activities, identify trends and risks within clinical trial data, and support continuous improvement initiatives. This individual will play a key role in shaping processes, establishing best practices, and growing the IDR function within the India organization.
Key Responsibilities
- Manage and develop the Integrated Data Review team in India, providing leadership, coaching, mentoring, and performance management.
- Collaborate closely with Clinical Data Management, Clinical Operations, Biostatistics, Medical Monitoring, Safety, and other global stakeholders to support study objectives.
- Develop, execute, and oversee study-specific Data Review Plans (DRPs).
- Lead Data Review Team meetings and drive productive discussions around data quality findings, trends, risks, discrepancies, and action items.
- Perform integrated review of clinical, operational, safety, and external data to identify inconsistencies, anomalies, and potential quality issues.
- Analyze data trends and quality signals using listings, dashboards, visualizations, patient profiles, and analytical reports.
- Investigate data issues, determine root causes, recommend corrective actions, and ensure timely issue resolution.
- Present data quality findings, risks, recommendations, and study insights to cross-functional stakeholders and leadership teams.
- Support query management, discrepancy management, escalation activities, and risk mitigation efforts across clinical studies.
- Contribute to database readiness and database lock activities by ensuring critical data review activities are completed.
- Develop and maintain clear, accurate, and high-quality documentation supporting data review activities.
- Partner with global leadership to establish and evolve IDR processes, standards, governance, and best practices.
- Drive continuous improvement initiatives and support innovation, automation, analytics, and modern data review approaches.
- Assist in building and scaling the Integrated Data Review capability within the India organization.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Statistics, Computer Science, Biotechnology, or related discipline.
Experience
- 7+ years of Clinical Data Management, Clinical Data Review, Data Quality Management, or related experience within the pharmaceutical, biotechnology, CRO, or healthcare industry.
- 4+ years of experience in Integrated Data Review, Data Quality Review, Risk-Based Data Management (RBDM), or similar clinical data review functions.
- Previous people management, team leadership, or study leadership experience.
- Experience working with global and cross-functional stakeholders.
- Experience leading meetings, presenting findings, and driving issue resolution.
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