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We are looking for a Manager, Trial Master File Operations, who will be responsible for the oversight of projects for TMF Technology within the Clinical Operations group. In this role they function as the subject matter expert to support the selection, implementation, and ongoing management of an in-house electronic Trial Master File (eTMF) solution and future innovations.
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The team is responsible for taking products like Ghost, Anvil, and our Sentry Tower from paper sketches to operational systems. Own feature development and rollout for our products - recent examples include building a Software-in-the-Loop simulator for our Anvil product, characterizing and improving Ghost helicopter battery consumption with route planning, designing an autofocus control system for IR cameras.
$160,000 - $240,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Responsible for development and maintenance of Trial Master File (TMF) Maintain electronic and paper study binders to ensure compliance with applicable regulations. 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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Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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Responsible for the review and compliance of the Trial Master file (TMF). Responsible for the review and compliance of the Trial Master file (TMF). Cross Collaboration proficiency with other functions such as Clinical Development, Clinical Operations, Biostatistics, Statistical Programming, and Pharmacovigilance.
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Responsible for creating electronic job file folder for each project in Sage/Procore. The Project Accountant is responsible for processing the Document Control Forms, generated by the PM or APM, in Sage/Procore for all subcontractor commitments and purchase orders.
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The PBR will keep track of all cases using ONTRAC as well as a paper tickle file system. Acts as patient representative in any cases submitted via the Health Connector, paper or over the phone, assisting the patient in deciphering notices received from EOHHS. Assists patients in the redetermination process for MassHealth, Connector Care and or Health Safety Net.
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Understanding of data types, file formats, and common metadata used in biology, including high-dimensional experiments such as imaging, or high-throughput experiments such as peptide/biologics display.
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF) Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF.
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Manage open enrollment and program renewals, including partnering with HRIS to ensure data accuracy of file feeds, and with internal communications for event planning and communication strategy (wellness/benefits fair, flu shot clinic, fitness classes.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, R or Python, Data Warehouses, SharePoint.
$96,600 - $151,800 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Maintains Anesthesia and Operating Room Library and keeps catalog file up to date. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network.
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The Cataloguer and Collections Care Specialist will be part of a close-knit curatorial team and will also work closely with conservators and collections care specialists in the MFA’s Virginia Herrick Deknatel Paper Conservation Laboratory.
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Nasuni is a leader in the SaaS Hybrid Cloud File Storage market, growing at 30% year-over-year with an 88% Net Promoter Score (NPS), 120% Net Revenue Retention (NRR), and 98.5% customer retention.
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Perform hands-on fixes at the desktop and remote level, including installing and upgrading software, installing hardware, implementing file backups, and configuring systems and applications. Application support experience with BNA Income Tax Planner, CaseWare, CCH Axcess Tax, Thomson Reuters CheckPoint/PPC, QuickBooks Desktop, QuickBooks Online, StarPDM is preferred.
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file paper jobs in Dorchester Center, MA
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