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Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems. Expertise in Veeva Vault or similar clinical trial management systems (CTMS), electronic trial master file (eTMF), or regulatory document management systems.
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Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF completion guidelines, edit check specifications, and data management plans identifying and mitigating risks to data quality and proper inclusion into the Trial Master File (eTMF.
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Strong background knowledge of English language proficiency assessments for multilingual learners and current qualifications and certificates to administer WIDA assessments (i.e., WIDA Screener for Kindergarten and WIDA Screener Online and Paper Based Test.
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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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Receive and process envelopes copy paper and special orders for 10 Park Plaza Boston RMV sites and Highway Districts. Delivery of copy paper paper cups and miscellaneous supplies at 10 Park Plaza Boston as needed.
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Responsible for development and maintenance of Trial Master File (TMF), Assists PI with protocol and consent form development for initial application and with subsequent amendment changes. Responsible for development and maintenance of Trial Master File (TMF), Assists PI with protocol and consent form development for initial application and with subsequent amendment changes.
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Become familiar with all U. S. Department of Transportation (DOT)/Environmental Protection Agency (EPA) and VES-TS regulations required in submitting paper work to expedite disposal of hazardous waste.
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Technology: Laptops, smartphones, and/or tablets provided to clinical staff, Full use of practice management software (i.e., CentralReach) for ease in client file management, client programming, report writing, and data collection, HIPAcompliant telehealth platforms and resources for cases that require it.
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Design analysis file specifications in accordance with the statistical analysis plan and table shells, and CDISC ADaM standards if applicable. Provide statistical input for Data Monitoring Committee (DMC) activities, including development of DMC charters and analysis plans, and serve as an independent statistician providing data and analysis support for DMC review.
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Good understanding of a virtualization infrastructure VMware, KVM, Hyper-V, deployment of datastore for VM provisioning on various type of storage media VMFS block, NFS file shares or NVMe-TCP. Good understanding of a database or VM administrator lifecycle.
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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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Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.
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This role involves close collaboration with our R&D, engineering, and legal teams to identify patentable inventions, draft and file patent applications, and ensure robust protection of our technological advancements.
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Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents. The Senior Manager will co-author and manage TMF documents such as TMF Plan, Index, SOPs, and other guidance documents.
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Examination room turnaround is to include and review the following: exam table paper, freshen pillow, residual materials from exiting patient, any floor or room debris, and insure that the examination room is ready for the next patient.
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