Medical Data Review Associate Manager
Company: Fortrea
Job Title: Medical Data Review Associate Manager
Location: Bangalore, India
Work Mode: Hybrid / Remote (as per business requirements)
Employment Type: Full-Time
Job Requisition ID: 262943
Application Deadline: June 30, 2026
About Fortrea
Fortrea is a leading global Contract Research Organization (CRO) providing clinical development, patient access, and technology solutions to pharmaceutical, biotechnology, and medical device companies worldwide. With operations across multiple countries, Fortrea helps bring innovative therapies to patients through scientific expertise, operational excellence, and advanced clinical technologies.
Position Summary
The Medical Data Review Associate Manager is a key member of Fortrea's Global Medical Review Team responsible for executing Central Medical Review activities within the organization's Central Monitoring strategy. The role focuses on reviewing clinical trial data to identify patient safety concerns, protocol deviations, data quality issues, and potential safety signals while supporting risk-based monitoring initiatives.
The position collaborates closely with Project Physicians, Clinical Operations, Data Management, Biostatistics, and sponsors to ensure accurate medical review, proactive risk identification, and effective communication of findings throughout the clinical trial lifecycle.
Key Responsibilities
Central Medical Review Activities
Execute Central Medical Review activities across global clinical studies.
Conduct ongoing medical review of clinical trial data using Central Monitoring methodologies.
Identify patient-level and site-level data trends, inconsistencies, and safety concerns.
Review clinical data under approved Central Medical Review Plans.
Collaborate with Project Physicians to evaluate findings and determine appropriate actions.
Escalate significant medical or patient safety concerns when necessary.
Risk-Based Monitoring & Safety Signal Detection
Assess clinical data to identify:
Patient safety risks
Emerging safety signals
Data quality concerns
Protocol compliance issues
Perform cumulative safety assessments and signal detection activities.
Support risk assessment processes and contribute to risk mitigation strategies.
Recommend actions based on data-driven clinical insights.
Study Planning & Medical Review Configuration
Draft, review, and maintain:
Central Medical Review Plans
Central Monitoring Plans
Medical Review Configuration Plans
Support study-specific review strategy development.
Contribute to Critical Data and Process Definition activities.
Assist in Electronic Data Capture (EDC) design implementation.
Define medical review requirements and study visualizations.
Xcellerate® Medical Review (XMR) Management
Configure and maintain the Xcellerate® Medical Review (XMR) platform.
Design study-specific dashboards and visualizations.
Perform User Acceptance Testing (UAT) for system configurations.
Ensure medical review tools remain aligned with protocol and study objectives.
Update configurations throughout the study lifecycle as required.
Cross-Functional Collaboration
Work closely with:
Project Physicians
Clinical Operations Teams
Data Management
Biostatistics
Programming Teams
Sponsors
Central Monitoring Teams
Ensure consistent execution of centralized review activities.
Provide medical review expertise to internal and external stakeholders.
Client & Sponsor Support
Contribute to proposal development and bid defense presentations.
Support preparation of proposal text and budget reviews related to Central Medical Review.
Participate in sponsor meetings and project discussions.
Maintain effective communication with clients regarding review findings and study progress.
Quality, Compliance & Inspection Readiness
Maintain inspection readiness for medical review activities.
Support audits and regulatory inspections when required.
Ensure compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
Regulatory requirements
Internal quality standards
Ensure accurate documentation of review findings and actions.
Continuous Improvement
Identify process improvement opportunities.
Recommend enhancements to systems, tools, and workflows.
Contribute to organizational best practices for centralized monitoring and medical review.
Support innovation initiatives related to clinical data review.
Training & Mentorship
Train new team members on medical review processes and project-specific requirements.
Provide mentorship and knowledge sharing within the team.
Support competency development and continuous learning initiatives.
People Management Responsibilities
(Applicable when functioning as a Line Manager)
Manage direct reports and team performance.
Conduct performance reviews and development discussions.
Ensure training compliance and utilization targets are achieved.
Participate in recruitment and onboarding activities.
Cascade organizational updates and departmental communications.
Support operational planning and workforce management.
Ensure smooth functioning of assigned Central Monitoring activities.
Educational Qualifications
Required
One of the following:
MBBS / Medical Degree
Allied Health Sciences Degree
Postgraduate Degree in Life Sciences
Pharmacy (B.Pharm / M.Pharm)
Biotechnology
Clinical Research
Other relevant healthcare or scientific qualifications
Equivalent experience may be considered in lieu of formal educational requirements.
Experience Requirements
Required
Experience in:
Clinical Data Review
Central Monitoring
Medical Monitoring
Clinical Data Management
Clinical Research Operations
Pharmacovigilance or Drug Safety (preferred)
Preferred
Experience within a CRO, pharmaceutical, or biotechnology environment.
Exposure to risk-based monitoring methodologies.
Experience reviewing clinical trial data and patient safety information.
Experience working with centralized review platforms and clinical databases.
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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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
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 :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
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 :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
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 :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
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 :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
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 | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |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 :
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 :
Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |Remote :
Hungary | McFarland | Medan | Nairobi | Castlebar | Remote - Middle East | Riga | Slovakia | Victoria | Remote - Europe | French | Remote - South America (Latin Americal) | Leinster | Zaragoza | Melbourne | Thailand | Hammond | Ireland | Blue Bell | Texas | Bountiful | Remote - Africa | Faridabad | Switzerland | Xzagreb | Tulsa | Bishop | Milwaukee | Springville | Perth | Lenexa | Lousiana | Green Way | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Manipal | Belgium |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Khulais | Jeddah | Najran | King Abdullah Economic City | Rabigh | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
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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