Amgen
Amgen

Senior Associate Medical Data Reviewer

RoleHealthcare
LevelMid Level
LocationHyderabad, India
WorkOn-site
TypeFull-time
Posted1 day ago
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About the role

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.

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

.

Benefits and perks

Learning Budget

Required skills

Medical review

Clinical data

Safety assessment

Signal detection

Clinical judgment

About Amgen

India - Hyderabad

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