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Manager, Integrated Data Review and Quality

Regeneron·Hyderabad

Pay not stated7–13 yrsFull-time

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About the role

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.

What you'll do

  • 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
  • Manage Integrated Data Review activities in line with established methodologies, standards, processes, and governance requirements
  • 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

What you need

  • 7–13 yrs of experience
  • Clinical data management
  • Quality control
  • Documentation
  • SOP writing
  • CRO
  • Root cause analysis
  • B.Sc or B.Tech or B.E. or BCA

Good to have

  • Data privacy
  • Compensation and benefits

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