Senior TMF Specialist
Location: Chennai, India
Work Model: Office-Based (Office with Flex)
Job Type: Full-Time
Job Requisition ID: JR146301
About ICON
ICON is a global healthcare intelligence and clinical research organization committed to accelerating the development of innovative medicines and treatments that improve patient lives worldwide.
Guided by our core values of Integrity, Collaboration, Agility, and Inclusion, we foster an environment where talented professionals can contribute to meaningful healthcare advancements while advancing their careers.
Position Overview
We are seeking an experienced Senior TMF Specialist to support and oversee Trial Master File (TMF) review activities for global clinical studies. This role requires strong expertise in TMF management, periodic file reviews, document completeness assessments, inspection readiness, and electronic Trial Master File (eTMF) systems.
The ideal candidate will have extensive experience performing co-dependency checks, cross-checks, and identification of missing documents, ensuring that TMFs remain complete, compliant, and inspection-ready throughout the clinical trial lifecycle.
Key Responsibilities
TMF Review & Inspection Readiness
Perform comprehensive periodic and milestone-based TMF reviews.
Conduct eTMF completeness assessments to ensure document quality and regulatory compliance.
Ensure assigned studies maintain continuous inspection readiness.
Identify and resolve TMF gaps, inconsistencies, and compliance issues.
Document Completeness & Quality Control
Conduct:
Co-Dependency Checks
Cross-Checks
Missing Document Identification
Quality Reviews
Verify that all required study documents are filed correctly and within established timelines.
Review document relationships and dependencies to ensure completeness across study records.
Expected Document List (EDL) Management
Review and maintain the Expected Document List (EDL).
Update document expectations based on study progress and protocol requirements.
Ensure all required documentation is accounted for throughout the study lifecycle.
eTMF Management
Utilize electronic Trial Master File (eTMF) systems to manage study documentation.
Support ongoing maintenance and organization of TMF records.
Ensure accurate filing, indexing, and retrieval of study documents.
Veeva Vault Review Activities
Perform TMF review activities within Veeva Vault.
Verify document completeness, metadata accuracy, and filing consistency.
Support system-based quality reviews and compliance assessments.
ALCOEA Compliance & Metadata Review
Conduct ALCOEA reviews to ensure documentation is:
Attributable
Legible
Contemporaneous
Original
Accurate
Enduring
Available
Review metadata fields for accuracy, completeness, and regulatory compliance.
Ensure document quality standards are consistently maintained.
Stakeholder Collaboration
Work closely with:
Study Teams
TMF Leads
Clinical Operations Teams
Quality Teams
Sponsors and Clients
Gather review requirements and align TMF activities with study objectives.
Provide status updates and recommendations regarding TMF quality and completeness.
Issue Resolution & Follow-Up
Track and manage TMF review findings.
Follow up with study teams to obtain missing documentation.
Monitor action items through completion and closure.
Escalate critical compliance risks when necessary.
Training & Knowledge Sharing
Deliver training sessions to internal teams on TMF processes and review methodologies.
Provide guidance on TMF best practices, compliance requirements, and inspection readiness.
Support team development through knowledge-sharing initiatives.
Service Delivery & Performance
Ensure all TMF review activities are completed according to agreed Service Level Agreements (SLAs).
Maintain high-quality deliverables and adherence to project timelines.
Support continuous process improvement initiatives within the TMF function.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Pharmacy
Biotechnology
Healthcare Sciences
Related Scientific Discipline
Preferred
Advanced degree in a scientific or healthcare-related field.
Experience
Required
Minimum 5 years of Trial Master File (TMF) experience.
Proven experience conducting periodic TMF reviews and completeness assessments.
Minimum 2–3 years of experience performing:
Co-Dependency Checks
Cross-Checks
Missing Document Identification
Inspection Readiness Reviews
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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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 :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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 :
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Boulder | Denver | Westminster |Connecticut :
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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 :
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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 :
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 :
Renfrew | Uxbridge | Mississauga | North York | Australia | Richmond Hill |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 :
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 :
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Bangkok |Israel :
Tel Aviv | Kfar Saba | Yavne | Netanya | 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 :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
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