Senior Associate Medical Data Reviewer
Amgen · Hyderabad, India
The apply link worked recently (not employer-confirmed).
Role summary
This role involves reviewing clinical trial data throughout development to maintain data quality, integrity, and safety. The Senior Associate applies medical expertise to evaluate adverse events, laboratory values, and other safety endpoints while identifying clinically meaningful signals and trends. The position requires collaboration across clinical operations, data management, and safety teams, with opportunities to enhance review processes and tools.
What they're looking for
- Experience reviewing large, complex clinical trial datasets
- Understanding of clinical data review processes and GCP study conduct
- Proficiency with clinical data analysis or visualization tools such as Spotfire or Power BI
- Ability to interpret complex clinical datasets and communicate findings clearly
- Strong written and verbal communication for cross-functional and leadership presentations
What you'll be doing
- Conduct ongoing medical review of clinical trial data for accuracy, consistency, and clinical relevance
- Evaluate adverse events, laboratory data, vital signs, ECGs, imaging, and safety/efficacy endpoints
- Identify trends, outliers, protocol deviations, and emerging safety signals across studies
- Partner cross-functionally with Clinical Operations, Data Management, Safety, and Biostatistics to resolve data issues
- Author and maintain defensible medical documentation to support regulatory inspection readiness
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.