Senior Associate – Medical Data Reviewer
Location: Hyderabad, India
Company: Amgen
Employment Type: Full-Time
Job Summary
The Senior Associate – Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, consistency, and interpretability of clinical trial data throughout the drug development lifecycle. The role combines clinical expertise with analytical data review capabilities to identify safety concerns, detect emerging signals, improve data quality, and support evidence-based decision-making.
This position plays a critical role in safeguarding patient safety by conducting ongoing medical review of clinical trial data, identifying clinically meaningful findings, and collaborating with cross-functional teams to ensure regulatory readiness and high-quality study execution.
Key Responsibilities
Clinical Data Review
Perform ongoing medical review of clinical trial data to ensure accuracy, completeness, consistency, and clinical relevance.
Review and evaluate:
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Laboratory Data
Vital Signs
ECG Findings
Imaging Results
Safety and Efficacy Endpoints
Identify data inconsistencies, anomalies, and missing information requiring further investigation.
Ensure clinical data quality throughout study conduct.
Safety Signal Detection & Risk Assessment
Monitor clinical datasets to identify:
Emerging safety signals
Safety trends
Outliers
Protocol deviations
Potential risks to patient safety
Apply medical judgment to distinguish clinically meaningful findings from normal variability.
Escalate critical findings and support risk mitigation activities.
Contribute to proactive safety surveillance and benefit-risk assessments.
Study Support & Medical Oversight
Provide medical input during study startup and planning activities.
Support risk assessments and medical data review strategies.
Assist in the development of study-specific monitoring and review plans.
Ensure medical review activities align with protocol requirements and study objectives.
Cross-Functional Collaboration
Collaborate closely with:
Clinical Operations
Data Management
Pharmacovigilance / Drug Safety
Biostatistics
Medical Monitoring
External Vendors
Support resolution of data quality issues and clinical queries.
Participate in study review meetings and governance discussions.
Contribute to issue escalation and decision-making processes.
Clinical Analytics & Visualization
Utilize data visualization and analytics tools to support medical review activities.
Work with platforms such as:
Spotfire
Power BI
Other Clinical Data Visualization Tools
Analyze large and complex clinical datasets to identify trends and insights.
Support development and enhancement of dashboards and review tools.
Documentation & Inspection Readiness
Author and maintain accurate medical review documentation.
Ensure inspection-ready records and traceable decision-making processes.
Support audit and regulatory inspection activities.
Maintain compliance with GCP, regulatory requirements, and internal SOPs.
Process Improvement & Innovation
Identify recurring data quality issues and systemic trends.
Recommend process enhancements to improve clinical data review efficiency and effectiveness.
Contribute to development of review standards, workflows, and best practices.
Support continuous improvement initiatives within clinical development operations.
Required Qualifications
Education
One of the following:
MBBS
MD
PharmD
BDS
BAMS
BHMS
Other relevant healthcare or medical degree with clinical research experience
OR
Master’s Degree in:
Life Sciences
Pharmacy
Public Health
Clinical Research
Related Scientific Discipline
OR
Bachelor’s Degree in:
Life Sciences
Pharmacy
Nursing
Related Healthcare Discipline
Experience
5+ years of experience in Clinical Research, Clinical Development, Medical Review, Data Review, Medical Monitoring, or Clinical Operations.
Experience within pharmaceutical, biotechnology, or CRO environments.
Experience reviewing clinical trial data and safety information.
Experience working within GCP-regulated clinical studies.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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