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

Manager, Integrated Data Review and Quality

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