1w
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Associate Director, TMF Lead
United States
$160k-$180k/yr RemoteFull Time
10+ YOE10+ years clinical research experience with TMF management, experience transitioning outsourced to in-house TMF, expertise in TMF structure and regulatory requirements, bachelor's degree (advanced preferred).
Veeva Vault eTMF
1w
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Senior TMF Lead
Maidenhead or King of Prussia
OnsiteFull Time
Extensive clinical research experience building and maintaining TMF infrastructure, knowledge of ICH/FDA/EU GCP, vendor oversight and people management experience, proficiency with MS Office and eTMF platforms, strong communication and judgment.
Veeva Vault, Electronic Trial Master File (eTMF), Microsoft Word, Microsoft PowerPoint, Microsoft Project, Microsoft Excel
3d
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TMF Lead II - FSP - US
Durham or United States
$100k-$118k/yr RemoteFull Time
7+ YOE7+ years clinical research experience with 5+ years TMF experience; BS/BA or MS/MA with relevant experience; knowledge of ICH/GCP, regulatory document requirements, Microsoft Office and eTMF systems.
Microsoft Office, Adobe Acrobat Standard, eTMF, UCV
3mo
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Associate Director, TMF Operations
Princeton, New Jersey, United States
$140k-$180k/yr OnsiteFull Time
10+ YOE5+ Mgmt10+ years clinical research with TMF; at least 5 years TMF process management; TMF systems experience (Veeva preferred); ICH-GCP knowledge; strong communication; onsite in Princeton (3 days/week).
Veeva eTMF, eTMF, CTMS, EDMS, ISF, CDMS/EDC
20h
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Associate Director, TMF Operations Lead
United States
$191k-$220k/yr HybridFull Time
8+ YOE8+ years TMF/clinical operations experience, university degree or equivalent, knowledge of ICH-GCP and ALCOA+, strong communication and organizational skills, proficiency with Microsoft Office, Smartsheet, and SharePoint.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Smartsheet, SharePoint
4w
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Senior Director, TMF Services
Princeton or Philadelphia or Raleigh
RemoteFull Time
12+ YOE10+ MgmtBachelor's in life/health sciences, 12+ years clinical operations/TMF experience, 10+ years management, expertise with eTMF platforms (Veeva Vault, TI, Wingspan, Medidata), Microsoft Office proficiency, P&L and business development experience.
Veeva Vault, TI, Wingspan, Medidata, eTMF, GlobalLink, Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint, CDISC TMF Reference Model, AI/ML
3mo
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Clinical TMF Manager, Clinical Operations
Redwood City, California, United States
$143k-$178k/yr OnsiteFull Time
8+ YOE2+ Mgmt8+ years in pharma/regulatory environment; 6+ years records management; TMF/CTMS expertise; FDA/ICH/GCP knowledge; vendor management experience.
eTMF, CTMS, Microsoft Office, MS Project, Smartsheet
1mo
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Entry-Level TMF Administrator
Cincinnati, Ohio, United States
OnsiteFull Time
Associates degree or equivalent, some document administration experience, high attention to detail, strong organization and communication, knowledge of Microsoft Office.
Microsoft Office
3mo
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Entry-Level TMF Administrator
Cincinnati, Ohio, United States
OnsiteFull Time
Associates degree or equivalent; some document administration experience; high attention to detail; strong organizational, written and verbal communication skills; knowledge of Microsoft Office.
Microsoft Office
2w
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Entry-Level TMF Operations Associate
Cincinnati, Ohio, United States
OnsiteFull Time
Associates degree or equivalent, some document administration experience, high attention to detail, excellent organization and communication, knowledge of MS Office.
MS Office
2mo
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Document and Clinical Systems Manager (TMF)
San Diego, California, United States
$131k-$179k/yr OnsiteFull Time
6+ YOEBS/BA in life science with 6+ years of clinical trial documentation; or MS with 4+ years; TMF/eTMF/CTMS experience; FDA/GCP/ICH knowledge; strong leadership and project management; MS Office.
Veeva CTMS, eTMF, TMF, TMF Plans, TMF Index, MS Office
2mo
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SSU & Regulatory Coordinator (Contract Management Assistant)
United States
RemoteContract, Full Time
Contract management coordination; experience in site start-up activities; regulatory submissions; TMF/documentation management.
Regulatory Submissions, Contract Management, TMF
2mo
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Director, Trial Master File
Watertown, Massachusetts, United States
$195k-$275k/yr OnsiteFull Time
10+ YOE10+ years in biotech/pharma with TMF/eTMF experience; process improvement; regulatory compliance; cross-functional collaboration.
TMF/eTMF, regulatory systems, document management
1mo
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Senior Manager Global Study Start Up
Warren or Armonk
$134k-$219k/yr OnsiteFull Time
8+ YOE2+ Mgmt8+ years in clinical trial start-up, leadership, site start-up management, CTMS/TMF proficiency, regulatory knowledge.
CTMS, TMF, Microsoft Office
3mo
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Clinical Trial Specialist
Phoenix, Arizona, United States
OnsiteFull Time
1+ YOEAssociate or higher degree in biological sciences; 1-2 years in biorepository/clinical trial; MS Office; experience with TMF and regulatory docs.
Microsoft Office Suite, TMF, LIMS, Sample Management System
3mo
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Senior Clinical Trial Manager (CTM)
United States
$168k-$188k/yr RemoteFull Time
5+ YOE2+ MgmtSenior CTM with 5+ years directing clinical trials in sponsor/CRO settings; strong GCP/ICH knowledge; regulatory submissions; TMF management; budget oversight.
TMF, GCP/ICH, Regulatory Submissions, Data Management, Biostatistics, Safety, Clinical Operations
1mo
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Study Manager
Miami, Florida, United States
$85k-$95k/yr OnsiteFull Time
2+ YOEMinimum 2 years clinical research coordination/project management; knowledge of FDA regulations and ICH/GCP; strong planning, communication, team leadership, TMF and study documentation oversight.
TMF
4d
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Site Management Associate II
Durham, North Carolina, United States
HybridFull Time
2+ YOECollege degree or equivalent; minimum 2 years clinical research or related administrative experience; proficiency in Microsoft Word/Excel/Outlook/PowerPoint; TMF and EDC familiarity; typing 40 wpm.
Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft Power Point, TMF, EDC
5d
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Site Activation Leader
United States
RemoteFull Time
4+ YOE4+ years clinical research operations experience with site activation, strong project management, GCP knowledge, CTMS/EDC/IXRS/TMF proficiency, bachelor\u0002s degree, stakeholder and team leadership skills.
CTMS, EDC, IXRS, TMF
1mo
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Clinical Research Associate II - Psychiatry - United States (Remote)
Durham or United States
$80k-$159k/yr RemoteFull Time
2+ YOE2+ years as a regional/traveling CRA, psychiatric monitoring experience required, 4-year degree or nursing degree, proficiency with Microsoft Office, CTMS, EDC, TMF, strong communication and organizational skills, willingness to travel regionally.
Microsoft Office, CTMS, EDC Systems, TMF
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