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Senior Medical Data Reviewer

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Amgen

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Location:
India , Hyderabad

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Category:
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Salary:

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Job Description:

In this vital role, the Senior Medical Data Reviewer is accountable for quality oversight of the Medical Data Reviewer (MDR) team across multiple Therapeutic Areas (TAs). This role is accountable for end-to-end clinical data review quality and delivery. The Senior Medical Data Reviewer provides people leadership to Medical Data Reviewers, serves as the point of escalation for complex clinical data issues, and partners cross-functionally to drive inspection readiness, compliance, and operational excellence.

Job Responsibility:

  • Directly manage and develop Medical Data Reviewers, establishing clear expectations, accountability, and performance standards
  • Build team capability through hiring, coaching, training, and succession planning
  • Oversee Medical Data Review & Signal Detection ensuring high-quality review of adverse events, labs, vitals, ECGs, imaging, and key endpoints. Identify trends, outliers, protocol deviations, and emerging safety signals
  • Serve as an escalation point for complex clinical data issues
  • providing expert clinical judgment to resolve complex or ambiguous data
  • Drive quality, compliance and risk management ensuring regulatory-ready documentation aligned with ICH-GCP, applying RBQM principles and leveraging KRIs/QTLs
  • Provide medical insight and strategic guidance to cross-functional partners to align data review outputs with study objectives and regulatory expectations
  • Strengthen and harmonize medical data review practices by advancing standardization, analytics adoption, and continuous process improvement

Requirements:

  • Doctorate + 4 years OR Master’s +8 years
  • 5–7+ years in biopharma/CRO clinical research
  • 2+ years people management experience
  • Experience reviewing large, complex clinical datasets
  • Strong understanding of RBQM and inspection readiness
  • Proficiency in data analytics/visualization tools
  • Strong clinical reasoning and communication skills

Additional Information:

Job Posted:
March 19, 2026

Work Type:
On-site work
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