Senior Associate – Medical Data Reviewer
Company: Amgen
Location: Hyderabad, India
Department: Clinical Development
Job Type: Full-Time
Work Mode: On-Site
JOB OVERVIEW
The Senior Associate – Medical Data Reviewer is responsible for ensuring the clinical integrity, quality, and interpretability of clinical trial data throughout the clinical development lifecycle. The role involves performing ongoing medical review of safety and efficacy data, identifying clinically meaningful trends and safety signals, supporting risk assessments, collaborating with cross-functional teams, and maintaining inspection-ready documentation to support patient safety, regulatory compliance, and high-quality clinical research.
KEY RESPONSIBILITIES
Medical Data Review
Perform ongoing medical review of clinical trial data.
Assess clinical accuracy, consistency, and relevance of study data.
Review safety and efficacy endpoints throughout the study lifecycle.
Ensure data quality and clinical integrity.
Support timely identification of clinically significant findings.
Safety Data Evaluation
Review adverse events (AEs) and serious adverse events (SAEs).
Evaluate laboratory data, vital signs, ECGs, imaging, and other safety parameters.
Assess protocol deviations affecting patient safety.
Monitor patient safety trends across clinical studies.
Support clinical risk evaluation and mitigation.
Signal Detection & Clinical Assessment
Identify emerging safety signals and clinical trends.
Detect data outliers and inconsistencies.
Apply medical judgment to differentiate clinically meaningful findings from normal variability.
Recommend appropriate follow-up actions.
Support benefit-risk assessment activities.
Study Start-Up Support
Provide medical input during study start-up activities.
Support risk assessments and data review strategies.
Contribute to protocol review discussions.
Assist in establishing medical data review processes.
Support study planning activities.
Cross-Functional Collaboration
Partner with Clinical Operations teams.
Collaborate with Clinical Data Management.
Work closely with Pharmacovigilance and Drug Safety teams.
Coordinate with Biostatistics and external vendors.
Resolve clinical data issues through cross-functional collaboration.
Data Review Tools & Analytics
Support development of medical review dashboards.
Contribute to data visualization tools such as Spotfire and Power BI.
Improve medical review workflows and reporting processes.
Enhance clinical data review methodologies.
Support continuous process optimization.
Documentation & Compliance
Prepare inspection-ready medical review documentation.
Maintain accurate clinical review records.
Document review decisions and medical rationale.
Ensure compliance with ICH-GCP and regulatory requirements.
Support audit and inspection readiness.
Continuous Improvement
Identify systemic clinical data quality issues.
Recommend workflow and process improvements.
Strengthen medical review standards.
Participate in governance and data review meetings.
Support quality improvement initiatives across clinical development.
EDUCATIONAL QUALIFICATIONS
Required
One of the following qualifications:
MBBS
MD
PharmD
BDS
BAMS
BHMS
Or another recognized medical/healthcare degree with clinical research experience
OR
Master's Degree in:
Life Sciences
Pharmacy
Public Health
Clinical Research
Or a related healthcare discipline
OR
Bachelor's Degree in:
Life Sciences
Pharmacy
Nursing
Biotechnology
Clinical Research
Or a related healthcare discipline
EXPERIENCE REQUIREMENTS
Required
Medical Degree with clinical research experience
OR
Master's Degree with 5+ years of clinical research experience
OR
Bachelor's Degree with 7+ years of clinical research experience
Preferred
5+ years of experience in biotech, pharmaceutical, or CRO environments.
Experience reviewing complex clinical trial datasets.
Experience with clinical data review and study conduct.
Knowledge of GCP and regulatory requirements.
Experience using Spotfire, Power BI, or similar visualization tools.
Strong understanding of clinical safety data and risk assessment.
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Uxbridge | Renfrew | Mississauga | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Netanya | Yavne | Tel Aviv | Kfar Saba | Be'Er Sheva |Remote :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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