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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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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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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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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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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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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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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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Documents patient file according to APG/BIDHC policy and maintains patient confidentiality at all times. Job Summary: Reporting directly to the Practice Manager and Director of Nursing, this position is responsible for performing the duties of an office Registered Nurse as well as acting as a clinical resource for the medical practice.
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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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Ensure all investigational product supply activities are documented in the Trial Master File. This role includes the management and oversight of the planning, forecasting, packaging, labeling, distribution and return of clinical supplies for assigned clinical trials and collaborates closely with the broader CMC and Supply Chain Management team, as well as with key internal stakeholders such as Clinical Operations, Regulatory Affairs and Quality Assurance.
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Electronically file documents via PACER and State Court e-filing systems. Assist with loan transactions and closings Prepare documents for service of process as required Compile and prepare reports and presentations Document review projects as assigned Requirements 3+ years of experience as a paralegal or paralegal assistant.
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The duties primarily include maintaining and organizing files, mail management, scanning of documents, enter/upload data into PLAnet (OPLA's electronic alien file repository), conducting research and drafting documents.
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Frequent movement about inside the office to access file cabinets, office machinery, etc. 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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Provide general HR support Track new hire laptop distribution and collection Manage Employee Recognition Program Assist with HR File Audits FINANCE RESPONSIBILITIES: Manage the accounts payable process by approving expenses and invoices through Concur and inputting all bills received by mail or email into QuickBooks.
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file job in Dorchester Center, MA
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