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Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF). The Senior Clinical Research Associate (Sr. CRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure study subject safety, and successful data collection and integrity of the clinical trial.
$138,500 - $153,100 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Perform Trial Master File (TMF) reviews to ensure completeness and audit‐readiness. The Clinical Trial Associate, SSU will aid in study start up activities for Fractyl's global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Create eCRF specifications, design, develop and validate clinical trial setup in EDC. Adaptable to new ways of working using technology to accelerate clinical trial setup. Minimum of 10+ years’ experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
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Ensure the ongoing completeness of the electronic Trial Master File (eTMF). The Senior Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., DM, IRT, and eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’ Manage the biomarker operations and logistics to align with clinical trial schedule.
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Responsible for relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.) AbbVie is hiring a Senior Biomarker Program Manager who will connect science and operations to implement and then manage biomarker research in multiple Phase 1-3 clinical trials.
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Responsible for managing relationships with CROs and other vendors for all study activities including study start-up, close out, and completion of Trial Master File. Responsible for initial RFP obtainment and contributes to CRO/vendor selectionResponsible for setting up, negotiating, and monitoring Task Order invoice payments for CRO (direct service and pass through costs); as well as oversee scope change negotiations.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). Provide clinical trial support, mentoring, leadership, guidance, and direction to Clinical Research Associates (CRAs) assigned to clinical studies.
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As a Senior Clinical Trial Management Associate, you will be responsible for Contract Research Organization (CRO) oversight and execution of clinical studies. Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF.
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The File Clerk has an important responsibility within the Refugee Resettlement Program, the job of a file clerk is multifaceted and has high responsibility to protect client data and file organization.
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Knowledge of Trial Master File (TMF) or Electronic Data Capture (EDC) systems is a plus. Applies regulations which include but are not limited to GCP, GLP, 21 CFR Part 58 and 21 CFR Part 11, guidance document requirements, and study plan/protocol requirements to Preclinical and Clinical trial studies.
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trial master file jobs Title: clinical research Company: Parexel
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