Senior Associate – Medical Data Reviewer
Department: Clinical Development / Medical Review
Location: Hyderabad, India
Company: Amgen
Job ID: R-247300
Experience: 5–8+ Years
Education: MBBS, MD, PharmD, BDS, BAMS, BHMS, Nursing, Life Sciences, Pharmacy, Public Health
Role Summary
The Senior Associate – Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, and medical interpretability of clinical trial data throughout the drug development lifecycle. The role combines medical expertise, clinical research knowledge, and data analytics to identify safety signals, review clinical data trends, and support evidence-based decision-making.
The incumbent works closely with Medical Monitors, Clinical Operations, Pharmacovigilance, Data Management, Biostatistics, and Regulatory teams to ensure high-quality clinical trial conduct and patient safety.
Key Responsibilities
1. Medical Review of Clinical Trial Data
Perform ongoing medical review of clinical trial data.
Evaluate clinical data for:
Accuracy
Consistency
Completeness
Medical relevance
Review patient profiles and subject-level clinical data.
Ensure data supports protocol objectives and regulatory expectations.
2. Safety Data Review & Signal Detection
Review and assess:
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Laboratory Results
Vital Signs
ECG Findings
Imaging Data
Efficacy Endpoints
Identify emerging safety signals and unusual trends.
Escalate clinically meaningful findings to study leadership.
3. Clinical Data Analytics
Analyze large and complex clinical datasets.
Detect:
Data inconsistencies
Outliers
Protocol deviations
Missing data patterns
Safety concerns
Apply clinical judgment to distinguish true signals from background variability.
4. Study Start-Up & Risk Assessment
Support protocol review activities.
Participate in study risk assessments.
Develop medical review strategies and data surveillance plans.
Contribute to quality-by-design initiatives.
5. Cross-Functional Collaboration
Collaborate with:
Clinical Operations
Medical Monitoring
Data Management
Pharmacovigilance
Biostatistics
Regulatory Affairs
Clinical Scientists
External Vendors
Resolve clinical data queries and support study execution.
6. Medical Review Technology & Visualization
Utilize clinical data review tools including:
Spotfire
Power BI
Clinical Dashboards
Data Visualization Platforms
Support development and optimization of review tools and dashboards.
Drive data-driven clinical decision making.
7. Governance & Inspection Readiness
Participate in:
Medical Data Review Meetings
Safety Governance Reviews
Study Team Discussions
Prepare and maintain inspection-ready documentation.
Ensure compliance with:
ICH-GCP
Company SOPs
Regulatory Requirements
8. Continuous Improvement
Identify systemic data quality issues.
Recommend process improvements.
Enhance medical review workflows and standards.
Support organizational best practices.
Key Performance Indicators (KPIs)
Quality of medical review
Safety signal detection effectiveness
Data query resolution timelines
Inspection readiness metrics
Protocol deviation identification
Risk mitigation effectiveness
Stakeholder satisfaction
Continuous improvement contributions
Required Qualifications
Education
Preferred Clinical Degrees
MBBS
MD
PharmD
BDS
BAMS
BHMS
OR
Life Science Route
Master's Degree + 5 years Clinical Research Experience
OR
Bachelor's Degree + 7 years Clinical Research Experience
Preferred Experience
5–8+ years Clinical Research experience
Pharmaceutical, Biotechnology, or CRO background
Experience reviewing clinical trial data
Understanding of GCP and clinical trial conduct
Experience with data visualization tools such as Spotfire or Power BI
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