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Senior Associate Medical Data Reviewer

Amgen
Hyderabad, Telangana, India
On-site

About this role

About the Role The Senior Associate - Medical Data Reviewer ensures the clinical integrity, quality, and interpretability of data generated across the clinical development lifecycle. The role applies strong medical and scientific judgment to complex clinical datasets to safeguard patient safety, enable timely signal detection, and support regulatory-ready decision making. What You'll Do

  • Conduct ongoing medical review of clinical trial data to ensure accuracy, consistency, and clinical relevance.
  • Evaluate adverse events, laboratory data, vital signs, ECGs, imaging, and other key safety and efficacy endpoints.
  • Identify trends, outliers, protocol deviations, and emerging safety signals across studies.
  • Apply medical judgment to distinguish clinically meaningful findings from normal variability.
  • Provide medical input into study start-up activities, including risk assessments and data review strategy.
  • Partner cross-functionally with Clinical Operations, Data Management, Safety, Biostatistics, and vendors to resolve data issues.
  • Contribute to the development and refinement of medical review tools, visualizations, and dashboards (e.g., Spotfire).
  • Lead or contribute to data review meetings, governance discussions, and issue escalation processes.
  • Author and maintain clear, defensible medical documentation to support inspection readiness.
  • Drive continuous improvement by identifying systemic data quality trends and strengthening review standards and workflows. What We're Looking For
  • MBBS, MD, PharmD, BDS, BAMS, BHMS, or other relevant medical/healthcare degree with clinical research experience; OR Master’s degree in Life Sciences, Pharmacy, Public Health, or related field with 5+ years of clinical research experience; OR Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline with 7+ years of clinical research experience.
  • Understanding of clinical data review processes and study conduct within GCP environments.
  • Experience reviewing large, complex clinical trial datasets.
  • Experience with clinical data analysis or visualization tools (Spotfire, Power BI, or similar).
  • Ability to interpret complex clinical datasets and translate findings into clear, actionable insights.
  • Strong written and verbal communication. Nice to Have
  • 5+ years of experience in clinical research within biotech, pharmaceutical, or CRO environments.
  • Experience reviewing large, complex clinical trial datasets.
  • Understanding of clinical data review processes and study conduct within GCP environments.
  • Experience with clinical data analysis or visualization tools (Spotfire, Power BI, or similar).
  • Ability to interpret complex clinical datasets and translate findings into clear, actionable insights.
  • Strong written and verbal communication.

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