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Responsibilities may include Copy/Print Production/Copy Center, Copier Maintenance, Mail/Courier Services, Reception/Office Services, Shipping/Receiving, Inventory Services, Warehouse, File Room/Records File Services based on assigned location.
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Manage site regulatory documents and Trial Master File (TMF) Archival of site records including site 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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The Director Trial Master File (TMF) and Clinical Documentation spearheads the vision and strategy for records management of clinical trial documents. At least 12 years prior experience in industry, with at least 6 years in TMF management.
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Data entry, document management, file creation and previous records experience required. Organize, register, scan, and file invoices, checks, and other documents along with matching check stubs to invoices paid •Operate full-cycle A/P.
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Knowledge of fabrication, tools, maintenance of heavy equipment/parts, and repair; computer competent; attention to detail and accuracy; excellent math, organizational, and management skills; tact and ability to communicate on a professional level to employees of all levels from staff to senior management, both orally and in writing.
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Maintains current and historic resident lease files by creating a filing system for easy and convenient storage and retrieval, updating resident records as needed to document resident transactions and communications, providing security in the storage of records and files, and complying with the Company’s policies and procedures related to file storage and recordkeeping.
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Assist with document management systems, which may include downloading patents and file histories. Maintain accurate confidential files and data records for IP client files. Proactively manage responses to all sensitive issues with clients, cases, or department management to support Chair and department.
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Job Summary The Senior Principal Engineer, Infusion Systems, is a Systems Engineer with expertise managing product risk documentation for medical device products and collaborating with the broader R&D team to develop robust records for the Design History File. The engineer has responsibility for risk assessments and documentation for the Ivenix Infusion System during the product development process and throughout the product lifecycle.
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Participate with other records and information staff in overseeing effective maintenance of records management systems including Interwoven File Creation, RFID File Tagging and Programming, File Retrieval, and Re-Shelving.
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Interprets relevant data including master file records, tax account history, etc. Independently researches and interprets applicable databases including Integrated Case Processing (ICP), Service wide Electronic Research Program (SERP), Integrated Data Retrieval System (IDRS), Taxpayer Advocate Management Information System (TAMIS), and other applicable information.
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This position will perform duties as a specialist relating to the implementation, and management of all aspects of document control and records management throughout the information lifecycle for physical or electronic records.
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Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with Blueprint teams, CRO’s and vendors.
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Duties include the use of a records management system (database) for search, retrieval, and data entry, applying records retention schedules to files for the purposes of retention, archiving and disposition, and preparation and review of standard operating procedures, training materials, and file plans.
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With unwavering dedication to promote professional innovation, Canon Solutions America, Inc. helps drive sustainability, nurture efficiency, and regulate costs through the unification of comprehensive digital and traditional printing and document management solutions.
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