Sr. TMF Reviewer
Location: Bangalore, India
Company: Fortrea
Department: Clinical Operations / Trial Master File (TMF) Management
Employment Type: Full-Time
Role Summary
The Sr. TMF Reviewer is responsible for managing and reviewing electronic Trial Master Files (eTMF) across Phase I–IV clinical studies to ensure quality, completeness, compliance, and audit readiness. The role involves oversight of Trial, Country, and Site-level documentation, performing Audit Ready Checks, identifying missing artifacts, supporting audits and inspections, and ensuring adherence to ICH-GCP, regulatory requirements, and sponsor expectations.
This position serves as a key TMF subject matter expert, collaborating with study teams, quality groups, sponsors, and stakeholders to maintain inspection-ready documentation throughout the clinical trial lifecycle.
Key Responsibilities
eTMF Management & Oversight
Manage Trial, Country, and Site-level eTMF documentation.
Maintain electronic Trial Master Files (eTMF) for Phase I–IV clinical studies.
Ensure TMF compliance with:
ICH-GCP Guidelines
Regulatory Requirements
Sponsor SOPs
Fortrea SOPs
Support document lifecycle management from study start-up through close-out.
TMF Review & Quality Control
Perform comprehensive TMF reviews of:
Trial Artifacts
Country Artifacts
Site Artifacts
Review uploaded documents for accuracy, completeness, and context.
Ensure proper filing and classification within the TMF structure.
Perform mapping between Sponsor TMF Index and Fortrea UCV structure.
Audit Readiness & Compliance
Maintain TMF in a constant state of audit readiness.
Conduct Audit Ready Checks on all study documentation.
Identify:
Missing Documents
Incomplete Records
Incorrect Artifacts
Compliance Gaps
Ensure timely resolution of TMF deficiencies.
Document Tracking & Completeness Management
Initiate and manage "What's Missing" activities.
Track essential documents throughout all study phases.
Obtain missing or incomplete records from study teams.
Monitor TMF completeness against study milestones and TMF plans.
Audit & Inspection Support
Prepare TMFs for:
Internal QA Audits
Sponsor Audits
Regulatory Inspections
Participate in client audits and health authority inspections.
Support CAPA implementation and audit finding resolution.
Operational Issue Management
Identify TMF-related operational issues.
Investigate root causes and implement corrective actions.
Escalate critical quality and compliance risks.
Drive resolution of TMF process issues.
Reporting & Metrics
Support study teams with TMF status reporting.
Track and maintain TMF review metrics.
Monitor quality trends across studies and programs.
Alert management regarding recurring issues and compliance risks.
Client & Stakeholder Management
Collaborate with:
Study Teams
Clinical Operations
Quality Assurance
Sponsors
Regulatory Teams
Participate in study meetings and client discussions.
Ensure high levels of client satisfaction.
Process Improvement
Contribute to:
TMF Process Enhancements
Quality Initiatives
Productivity Improvements
Continuous Improvement Projects
Support training and knowledge-sharing initiatives.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Clinical Research
Pharmacy
Biotechnology
Business Administration
Related Discipline
Preferred Education
Master's Degree in:
Life Sciences
Clinical Research
Business Administration
Related Field
Experience
8–10 years of experience in Clinical Research.
Experience with:
eTMF Management
Clinical Documentation
Clinical Trial Operations
Regulatory Documentation Review
Experience supporting audits and inspections preferred.
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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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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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 :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
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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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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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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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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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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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South Africa | Midrand |Nišava District :
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