Build our future together:

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for people with serious diseases.

We are seeking a Manager, Integrated Data Review & Quality to provide operational leadership for integrated data review activities across our clinical development portfolio. You will manage and directly contribute to study-level data review, help identify and resolve data quality risks, and partner with cross-functional teams to deliver high-quality, inspection-ready clinical data. You may also lead and develop Integrated Data Review & Quality staff while supporting a culture of collaboration, accountability, and continuous improvement.

When & where:

Hyderabad (hybrid)

Discover your role:

- Manage Integrated Data Review activities in line with established methodologies, standards, processes, and governance requirements.
- Develop, execute, and be responsible for Data Review Plans for assigned studies, ensuring data quality issues and risks are identified, tracked, escalated, and resolved.
- Lead Data Review Team meetings and facilitate discussions on findings, discrepancies, trends, risks, actions, and issue resolution.
- Review and interpret clinical, operational, safety, and external data using listings, visualizations, dashboards, patient profiles, analytical reports, and discrepancy reports.
- Present data review findings, risks, trends,



and recommendations to study teams and cross-functional stakeholders.
- Manage study-level queries and discrepancies, including investigation, documentation, blocking issue, corrective action, resolution, and closure.
- Support database readiness and database lock by ensuring data review activities and quality issues are completed and resolved on time.
- Apply risk-based approaches to identify critical data and quality risks aligned with study objectives and critical-to-quality factors.
- Act as a subject matter expert for Integrated Data Review, Data Review Plans, discrepancy management, risk identification, and data quality issue resolution.
- Support SOPs, work instructions, templates, training materials, guidance, metrics, lessons learned, and process improvements.
- Contribute to initiatives involving analytics, automation, AI-enabled solutions, and integrated review across clinical and external data domains.
- Lead, coach, mentor, and develop team members, and support workload planning, resource allocation, priorities, and study deliverables, as applicable.

This role requires:

- A bachelor's degree in Life Sciences, Statistics, Computer Science, or a related field.




- At least 7 years of direct Clinical Data Management experience within biotechnology, pharmaceutical, CRO, or healthcare.
- At least 4 years of experience in Integrated Data Review, Data Quality Management, Risk-Based Data Management, or related clinical data review activities.
- At least 2 years of people management, team leadership, or equivalent experience leading study-level or cross-functional initiatives.
- Strong knowledge of clinical data management, integrated data review, data quality management, issue management, and clinical trial data flow.
- Experience developing and executing Data Review Plans and leading Data Review Team meetings.
- Experience reviewing clinical, operational, safety, and external data to identify trends, anomalies, inconsistencies, and quality risks.
- Experience leading study-level queries and discrepancies and driving root-cause analysis, corrective actions, and resolution.
- Solid understanding of Risk-Based Data Management and Risk-Based Quality Management principles.
- Solid understanding of ICH E6 (R3), ICH E8 (R1), GxP, 21 CFR Part 11, global data privacy requirements, and inspection readiness.
- The ability to lead and influence in a matrix organization and build strong partnerships across clinical development functions.
- Solid analytical, strategic, critical-thinking, stakeholder management, facilitation, negotiation, and communication skills.
- The ability to manage multiple studies, priorities, and competing deliverables in a fast-paced environment.
- Willingness to travel up to 25%, when required.

📌 Manager, Integrated Data Review and Quality (India)
🏢 Regeneron Pharmaceuticals
📍 India