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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) The Clinical Biospecimen Operations Manager responsible for the execution of oncology clinical research studies, including coordination of all operational activities required for tracking, testing and reporting clinical trial samples.
$111,900 - $139,900Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensures trial master file is current and maintained. OVERVIEWWe are currently searching for a skilled professional to join a well-known client’s team as a remote Clinical Trial Manager.
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Oversee site inspection readiness, including health of Trial Master File (TMF) 2+ years experience as a Lead CRA, Clinical Trial Lead or equivalent. Identify monitoring trends across clinical studies and communicate them within trial team and Clinical Operations Team.
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Extensive knowledge of a broad array of systems including Clinical Trials Management System (CTMS); Risk Based Monitoring (RBM); Electronic Trial Master File (eTMF); Electronic Data Capture (EDC); Clinical Studies Operational Data Warehouse & Analytics; Site Training and Resource Management etc.
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The Clinical Research Associate (CRA) is responsible for establishing and maintaining the Study Master File, tracks critical trial information, and supports Regional Clinical Research Associates under the guidance of a Clinical Manager or Clinical Director.
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Provide oversight and quality checks of CRO-managed Trial Master File. Familiarity with ICG/GCP, and FDA requirements governing clinical trial management. Track and reconcile clinical trial equipment, samples, imaging files, etc.
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You will develop, communicate, and own persona-specific go-to-market plans and product positioning that demonstrate to our customers the value of Medidata’s clinical trial financial management solutions, Grants Manager, and Site Payments, as well as our CTMS (Clinical Trial Management System) and eTMF (electronic Master File) solutions.
$135,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensure study compliance with Delix’s SOPs and regulatory guidelines by performing periodic quality control audits of the electronic trial master file (eTMF) throughout all study phases including study initiation, implementation, and closure.
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Manage site regulatory documents and Trial Master File (TMF) General Summary/Overview Statement: The Coordinating Center Senior Project Manager for the Center for Clinical Investigation Coordinating Center (CCI-CC) will report to and work closely with the CCI-CC Director in the development, implementation, and management of the clinical trial operations for ongoing clinical trials and research consortiums.
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Generation and/or maintenance of study documentation including protocols, informed consents, source documentation, case report forms, reports, subject enrollment logs, site & visit / monitoring logs, training logs, delegation of authority, device accountability, financial disclosure, CV’s / resumes & licensure and other trial master file documents.
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Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.
$55 - $64.29 an hourRemoteExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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The Intelligent Automation Architect will work closely with cross-functional teams to identify opportunities for automation, design and implement solutions, such as automations for Clinical trial agreements, contract management, site management relates tasks, trial master file management, to streamline/speed up tasks and ensure their effective/secure utilization, faster completion, error/cost reduction and data quality improvement.
$138,750 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Uploads of Clinical Supply Chain Documents file documents to the electronic Trial Master File (eTMF) Analyzes non-routine information or data to support Supply Chain activities – e.g., inventory levels, prices and tracking of shipments, inventory positioning, material deliveries, planned master production schedule and sales forecasts.
$40 - $42 an hourExpandApply NowActive JobUpdated Today
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