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The R&D IT Senior Business Analyst (BA) will play an active role in supporting GXP applications in the Clinical Sciences business area, specifically the electronic Trial Master File (eTMF.
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Perform Trial Master File maintenance. The Field Clinical Research Associate (Field Monitor) is primarily responsible to ensure the assigned site study staff conduct the study in compliance with the currently approved protocol/amendment(s) and trial operations manual.
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Ensure Meticulous Documentation: Oversee clinical and regulatory files, including the essential Trial Master File (TMF) Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements.
Full-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Oversee quality compliance activities related to the review of quality records, including Clinical Study Reports, Trial Master Files, Device History Records, Deviations, OOS reports, audit reports, Research and Development protocols and reports, and Software validation protocols and reports.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
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Responsible for development and maintenance of Trial Master File (TMF) The Division of Rheumatology, Allergy and Immunology (DRAI) at Massachusetts General Hospital (MGH) is seeking an intellectually curious and highly organized individual with supervisory experience to serve as a Research Project Manager in a clinical trial which will test two different treatment strategies for gout.
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Assists in the development and maintenance of a detailed schedule of QA/Reg milestones and deliverables; to include internal audits, quality improvement projects, Trial Master File (TMF) reconciliations, etc.
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Manage site regulatory documents and Trial Master File (TMF) 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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Preparation and oversight of Trial Master File (TMF) and internal files, including periodic reviews as per TMF plan. Visterra is seeking a Clinical Trial Manager (CTM) to join our dynamic team.
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Activities include coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with regulatory authorities and manufacturers, etc.
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This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management. Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets.
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TMF Management and Reporting: Handles and maintains electronic TMF and electronic internal repository according to ICH/GCP guidelines and applicable regulations/ standards. Due Diligence: Participates in Due Diligence activities related to TMF. Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.
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Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.
Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Project management of a clinical study from protocol development up to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving. A strong command of the drug development process, and specifically, each step within the clinical trial process.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations.
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trial master jobs in Waltham, MA
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