TMF Associate
Location: San Francisco, CA
Job Category: Contract
About the Role
Our client is seeking a Contract Trial Master File (TMF) Associate to support high-quality TMFs across ongoing and completed clinical studies, ensuring adherence to ICH-GCP guidelines, other regulatory requirements, and SOPs. This is a 6-month contract role based in South San Francisco with a hybrid schedule (4 days in the office, 1 day remote).
Key Responsibilities
Contribute to the development and management of paper and electronic TMF systems for clinical trials, ensuring completeness, accuracy, and regulatory compliance
Upload study documents into various eTMF platforms (e.g., Veeva)
Reconcile and conduct quality control (QC) for eTMF uploads
Ensure timely and accurate filing of essential documents per regulatory requirements and company SOPs
Collaborate with Study Teams to ensure the effective implementation of TMF Management Plans
Assist in the creation, maintenance, and tracking of TMFs for each assigned study
Perform regular reviews and quality checks of TMFs to ensure completeness, accuracy, timeliness, and consistency
Manage the transfer of study-specific TMF to designated parties
Act as a point of contact for Study Team TMF questions and address any discrepancies or missing documents
Support the close-out of TMF-related issues
Collaborate with cross-functional teams to ensure timely submission and retrieval of documents
Aid in the identification and resolution of documentation issues
Educate and support Study Teams on TMF-related responsibilities
Identify process improvement opportunities for TMF management and assist in updating SOPs, WIs, and training materials
Prepare and support TMF-related audits and inspections by regulatory authorities
Qualifications
Bachelor's degree required
2 years of TMF experience
Sponsor experience required
Veeva Vault experience preferred
Familiarity with regulatory requirements (ICH, GCP, FDA) for clinical trials
Experience with electronic Trial Master File systems and document management preferred
Proficient in MS Office applications (Word, Excel, Outlook)
Excellent organizational, communication, and problem-solving skills
Strong attention to detail with the ability to manage multiple tasks and prioritize effectively
Collaborative team player with the ability to educate and interact positively with diverse teams
Additional Information
CRN, a division of Solomon Page, provides a comprehensive benefits program, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits for hourly employees, including consultants.
Gujarat :
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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 | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | 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 :
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Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
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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 :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
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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 :
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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 | Mississauga | Uxbridge | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva | Yavne |Remote :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
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Jeddah | King Abdullah Economic City | Riyadh | Khulais | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |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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