Job Title
TMF Reviewer II (Trial Master File Reviewer)
Company
Fortrea
Location
Bangalore, India
Work Type
Hybrid
Employment Type
Full-time
Job Posting
Posted 5 days ago
Application deadline: June 4, 2026
Role Summary
This role is responsible for managing, reviewing, and ensuring compliance of electronic Trial Master Files (eTMF) for clinical trials. It focuses on maintaining audit-ready clinical documentation across all study phases in alignment with regulatory standards and sponsor requirements.
Key Responsibilities
TMF Management & Review
Perform review of electronic Trial Master Files (eTMF) across:
Trial level documents
Country-level artifacts
Site-level artifacts
Ensure proper classification, indexing, and organization of TMF documents
Conduct quality control checks on uploaded study documents
Map sponsor TMF index with internal systems (UCV / TMF tools)
Maintain TMF systems in audit-ready condition
Compliance & Quality Assurance
Ensure adherence to:
GCP (Good Clinical Practice)
ICH guidelines
Sponsor and internal SOPs
Perform audit-ready checks on documents for accuracy and completeness
Identify missing or incomplete TMF documents and track resolution
Support preparation for QA audits, sponsor audits, and regulatory inspections
Implement corrective actions for audit findings
Documentation & Tracking
Track essential clinical trial artifacts throughout study lifecycle
Ensure TMF completeness according to TMF plans and study milestones
Maintain accurate documentation and reporting metrics
Support data collection for study status reports
Issue Management & Communication
Identify and resolve TMF-related operational issues
Communicate document quality issues and trends to management
Collaborate with study teams and cross-functional stakeholders
Participate in client and internal study meetings
Ensure high client satisfaction through timely and accurate documentation
Process Improvement
Contribute to continuous improvement initiatives
Identify trends in documentation quality and suggest process improvements
Support enhancement of TMF workflows and systems
Required Qualifications
Bachelor’s degree in Life Sciences or Business-related field
OR equivalent experience in clinical research (accepted)
Experience Required
6 to 10 years of experience in clinical research environment
Strong understanding of:
GCP (Good Clinical Practice)
ICH guidelines
Clinical trial documentation processes
Technical Skills
Experience with:
Electronic TMF (eTMF) systems
Clinical document management tools
Proficiency in:
MS Office (Excel, Word, PowerPoint)
Adobe Acrobat
Familiarity with scanning, document control, and web-based applications
Knowledge of regulatory and clinical trial documentation requirements
Preferred Qualifications
Master’s degree in Life Sciences or Business
Experience using electronic clinical systems (eTMF platforms)
Behavioral Skills
Strong attention to detail
Excellent communication and interpersonal skills
Ability to work in structured, compliance-driven environments
Strong organizational and coordination skills
Ability to manage documentation under strict timelines
Team collaboration and stakeholder management
Work Environment
Hybrid office-based role
Occasional travel (<10%) for meetings or audits
Interaction with global study teams and sponsors
Core Role Summary (Simple View)
This job is mainly about:
Reviewing and managing clinical trial documents
Ensuring regulatory compliance of trial files
Keeping trial documentation audit-ready at all times
Supporting clinical trial inspections and audits
Working with eTMF systems and documentation workflows
Uttar Pradesh :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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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 :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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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 :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 | Renfrew | Uxbridge | 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 :
Estonia | Tartu |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 :
Japan | Saitama |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 :
Kfar Saba | Netanya | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Lima |France :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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Sofia |Sweden :
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Taipei |Mazovia :
Warsaw |
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