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Why LMK: LMK Clinical Research Consulting is a recognized leader in Trial Master File (TMF) document management services and solutions for the life sciences industry. What You Will Be Doing: LMK’s TMF Support Analyst is the Quality Control Expert and ensures accuracy and completeness of all clinical documentation within the TMF. The clinical trial documentation must be consistent with the Trial Master File Specifications, submission/inspection readiness criteria and comply with LMKs (or clients) SOPs and regulatory requirements.
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Experienced with document management and/or electronic trial master file systems (eTMF), for example, Wingspan, Documentum, Trial Interactive, Veeva Vault, etc. The Sr. Manager of Clinical Document Management and Inspection Readiness will provide support for Trial Master File (TMF) and inspection readiness (IR) activities to the Clinical Document Management team and to internal and external clinical study team members and functional areas.
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Clinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally.
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Lead a team delivering user support and knowledge management activities related to the delivery of capability and learning services to help drive adoption of Trial Master File (TMF) and good documentation practices across the business.
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As the Trial Master File (TMF) Specialist, you will be responsible for the day-to-day management of TMF, including oversight of the review and approval of TMF documents and generation of reports to measure completeness, accuracy, and timeliness of the TMF. This role works very closely with Clinical Operations and other departments that have a contribution to the TMF for studies.
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Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva) Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
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Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained. Previous experience with Next Generation Sequencing (NGS), Immunohistochemistry (IHC), and/or pathology.
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Maintenance of the Trial Master File and/or electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs. Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files.
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Trial Master File (TMF) Specialist will assist in and oversee all aspects of TMF Management. Lead, design, build and develop Trial Master File structure per applicable regulatory guidance.
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Maintain quality and compliant documentation related to all aspects of site management including quality and ALCOA+ compliant monitoring visit reports, centralized monitoring reports, site contact reports, Trial Master File/Investigator Site File, etc.
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Trial Master File Records Specialist (TRS) Responsibilities. The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team.
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8 years of mainframe experience in IBM JCL, CA7, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities. 8 years of mainframe experience in IBM JCL, CA7, JCL, and utilities, COBOL, REXX, EasyTrieve, VSAM, IDMS, Endevor, File Master, Dispatch, View, UniTech and Remedy utilities.
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Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews. The In-house CRA is an important member of the Alira Health Clinical team.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.
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Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.
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