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The Director, Clinical Operations (TMF, CTMS) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.
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Experience with clinical systems including various EDC, IRT, TMF, CTMS, etc. Collaborate with cross-functional teams (e.g., regulatory, translational research,quality, CMC, statistics, etc) in study start-up planning as well as to coordinateefforts for study deliverables (e.g., regulatory submissions, sample reconciliation,PK and exploratory biomarker analyses, SOP development, drug supply projections,pharmacy manual and IP management, developing data cleaning timelines forstats/programming TLF deliverables, etc.
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The Associate Director, Clinical Records & Information Management will partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF. This role is a member of the Clinical Records leadership team to ensure optimum implementation of the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program.
$191,335 - $247,610 a yearExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Responsible for reviewing TMF filing documents that originate from lab vendors, in accordance with regulatory requirements. Collaborate with the Clinical Development Team in clinical trial sample management including the strategy, planning, and vendor oversight of the processing, tracking, and reconciliation of biomarker, PD, PK, and other types of biological samples, collected for an assigned project.
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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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Familiarity with the organization and structure of the Trial Master File (TMF) Familiarity with the organization and structure of the Trial Master File (TMF) FBI Cyber Crime resource page. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
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Track GCP audits of vendors, sites and TMF and ensure findings are fed back into the GCP inspection readiness program or appropriate training or processes. Track GCP audits of vendors, sites and TMF and ensure findings are fed back into the GCP inspection readiness program or appropriate training or processes.
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Influence future TMF direction and capabilities by identifying and leading activities which build efficiencies, automation, standardization, and adoption of best practices across Gilead and Kite.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
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Clinical Trial, CTM, TMF, GCP, SOP, ICH, Microsoft Office. Clinical Trial, CTM, TMF, GCP, SOP, ICH, Microsoft Office. Lead or support the development of study plans and system set-up and UAT; participate in the preparation and ensure operational excellence of protocol, CRF, CSR, and other key study deliverables.
$80 - $90 an hourExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages. Provides operational and strategic input and/or approves clinical study documents, such as project timelines, protocols, investigator brochures, pharmacy manuals, laboratory manuals, informed consent, study start-up plans, monitoring plans, CRF Completion Guidelines and CSR.
$240,000 - $295,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday
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