Senior Associate Medical Data Reviewer

Responsibilities

• 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
• Author and maintain clear, defensible medical documentation to support inspection readiness
• Drive continuous improvement by identifying systemic data quality trends and strengthening review standards

Requirements

• 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

Preferred Qualifications

• 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 such as Spotfire or Power BI
• Ability to interpret complex clinical datasets and translate findings into clear, actionable insights
• Strong written and verbal communication skills with experience presenting to cross-functional audiences

About the Company

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world.