Amgen
Senior Associate Medical Data Reviewer
India · On-site · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerAmgen
- LocationIndia
- Work styleOn-site
- Employment typeFull time
- Employer posted
Career Category
Clinical
Job Description
In this vital role, the Senior Associate - Medical Data Reviewer is responsible for ensuring 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.
The position requires both clinical expertise and analytical rigor, with the ability to distinguish clinically meaningful signals from background variability and drive appropriate actions when required.
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.
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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 expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
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 (e.g., Spotfire, Power BI, or similar)
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 and leadership audiences
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At a glance
- Work styleOn-site
- Employment typeFull time
- SenioritySenior
- Employer posted
- Added to ROLIVA
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Skills in this posting
Skills ROLIVA found in the employer’s own description above. A mention is not a requirement.