Senior Associate Medical Data Reviewer

About the role

Medical Data Review Team at Amgen ensures clinical integrity and quality of data across the development lifecycle. The Senior Associate conducts ongoing medical review of trial data, evaluates safety and efficacy endpoints, identifies trends and signals, partners with Clinical Operations, Data Management and Biostatistics, and leads data review meetings and documentation. Hyderabad, India, on-site, relocation available.

What you’ll do

• Conduct medical review of clinical trial data for accuracy and relevance
• Evaluate adverse events, labs, vitals, ECGs, imaging and safety/efficacy endpoints
• Identify trends, outliers, protocol deviations and emerging safety signals
• Provide medical input to study start‑up activities and risk assessments
• Partner with Clinical Operations, Data Management, Safety, Biostatistics and vendors to resolve data issues
• Develop and refine medical review tools, visualizations and dashboards
• Lead data review meetings, governance discussions and issue escalations
• Author and maintain defensible medical documentation for inspection readiness
• Drive continuous improvement of data quality standards and workflows

What you’ll bring

• MBBS/MD/PharmD/BDS/BAMS/BHMS or related degree with clinical research experience
• Master's in Life Sciences/Pharmacy/Public Health with 5+ years clinical research
• Bachelor's in Life Sciences/Pharmacy/Nursing with 7+ years clinical research

Nice to have

• 5+ years clinical research in biotech/pharma/CRO
• Experience reviewing large complex clinical datasets
• Understanding of GCP clinical data review processes
• Proficiency with Spotfire or Power BI
• Ability to interpret complex datasets into actionable insights
• Strong written and verbal communication for cross-functional presentations

Skills