Manager, Integrated Data Review and Quality in Hyderabad, भारत

Regeneron seeks a Manager for Integrated Data Review & Quality to oversee clinical data review operations, manage data quality risks, and lead cross-functional teams in delivering inspection-ready data across the development portfolio. Based in Hyderabad on a hybrid arrangement.

Responsibilities

• Manage integrated data review activities and develop data review plans for assigned studies
• Lead data review team meetings and facilitate issue resolution, risk tracking, and corrective actions
• Review clinical, operational, and safety data to identify quality risks, trends, and discrepancies
• Present data review findings and recommendations to study teams and cross-functional stakeholders
• Lead, mentor, and develop team members while supporting workload planning and study deliverables

Requirements

• Bachelor's degree in Life Sciences, Statistics, Computer Science, or related field
• 7+ years direct clinical data management experience in biotech, pharma, CRO, or healthcare
• 4+ years integrated data review, data quality management, or risk-based data management experience
• 2+ years people management or cross-functional team leadership experience
• Proficiency in clinical data management, data quality, and risk-based quality principles
• Knowledge of ICH E6/E8, GxP, 21 CFR Part 11, and regulatory inspection readiness
• Strong analytical, stakeholder management, and communication skills; up to 25% travel willingness