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Project Summary: Support Clinical Trial Management teams with document processing activities, including uploading, reviewing, and indexing tasks in a Veeva-based electronic Trial Master File (eTMF.
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Extensive knowledge of 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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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.
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Responsibilities include, but not limited to: Filing clinical documents in the Trial Master File (TMF) Manage and/or support the Manager, Clinical Operations with oversight of the Trial Master File (TMF.
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Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files. Maintenance of the Trial Master File and/or electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
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Reviews study plans, including; Clinical Monitoring, Communication, Project Management and electronic Trial Master File (eTMF) Management. Strong understanding of the Trial Master File structure (TMF)Alumis Values Elevate Challenge NurtureThis position is located in South San Francisco, CA. At this time we are not considering remote applicants.
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Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF) Lead weekly meeting of the Clinical Trial Team on status of assigned studies.
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Upload documents such as labs, other clinical documents, and informed consent documents into established clinical trial management systems and/or electronic trial master file.
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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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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 (Senior), minimum of 15+ years’ experience (Principal) in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
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Review edit check specifications and program edit checks at the trial level. Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint.
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Leads and/or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan. Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review / clean up.
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As the Senior/Principal EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies. Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
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You will work with Takeda study team to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Work with leaders to resolve issues affecting the delivery of clinical trials.
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trial master file jobs Title: clinical research associate Company: Parexel
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