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Why LMK:LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions for the life sciences industry. At LMK, we believe the Trial Master File (TMF) is the foundation of every clinical trial, and a strong foundation is key to the overall health and stability of any clinical program.
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Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required.
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Support Inspection Readiness activities, such as, but not limited to: Local and/or Global Trial Master File (TMF) reconciliation and supping and/or maintaining sharerooms. Trial Master File (TMF) activities, such as, but not limited to: submitting documentation to Trial Master File (TMF), including addressing discrepancies, redaction, etc., and reconciling of trial documents and Run reports, as requested.
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Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports). Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports.
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Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
$73,780 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Texas Health Care Quality Improvement Award of Excellence - TMF Health Quality Institute. Houston Methodist Hospital is affiliated with the Weill Medical College of Cornell University and New York-Presbyterian Hospital, one of the nation's leading centers for medical education and research.
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Breast Imaging Center of Excellence - American College of Radiology. Certificate of Distinction for Primary Stroke Centers - DNV-Det Norske Veritas. Certificate of Distinction for Ventricular Assist Device - DNV-Det Norske Veritas.
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Accountable for overall TMF in the trial always ensuring inspection readiness. Gene Therapy and rare disease experience are highly desirable. Perform ongoing vendor management and oversight during the study, including review of performed work against budget, negotiation of scope of work, Change orders and budget amendments, performance management and issue resolution in close collaboration with the Clinical Operations program leader.
$77Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Lead/manage Good Clinical Practice (GCP) audits, including clinical investigator site audits, clinical vendor audits, clinical department internal audits, Trial Master File (TMF) audits, and applicable study document audits, including Clinical Study Reports (CSRs.
$144,800 - $170,300 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Innovative technology allows TMF to offer unmatched transparency in reporting and practice details, via the new EPiC opportunity overviews. The Medicus Firm (TMF), a part of M3USA, is a national retained physician search firm unlike any other.
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Provides cross-functional TMF oversight through the study life cycle. The Clinical Systems Analyst/Senior Clinical Systems Analyst performs eTMF system administrator duties and is responsible to ensure that the MacroGenics eTMF is maintained, upgraded and appropriately configured.
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This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical Study Oversight Plan,day-to-day management of DS Safety Notification Letter (SNL) System and manages uploads to TMF activities.
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This person will also assist with the inspection readiness of the electronic Trial Master File ([e]TMF) and provide support with study specific training, minute taking, creation/maintaining of trackers, and system access management for the CTT. In addition, the CTA will assist the Global Head of Trial Operations and Vice President of Global Clinical Operations with the logistics of the departmental meetings.
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Ensure archival of all Data Management Trial Master File (TMF) documents. Ensure archival of all Data Management Trial Master File (TMF) documents. Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.
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7+ years of experience supporting Pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM) 7+ years of experience supporting Pharmaceutical content management solutions and integration (Authoring, Submissions, Archival, TMF, Quality, DAM, PLM.
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