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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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Responsible for supporting the management, oversight (CRO) and maintenance of the Trial Master File (TMF) Lead both an internal and external/CRO trial management team, to ensure the successful conduct of the trial in accordance with State and Federal regulations, GCP regulations, ICH guidelines, and internal SOPs.
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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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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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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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Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF). The Senior Clinical Research Associate (Sr. CRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure study subject safety, and successful data collection and integrity of the clinical trial.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Create eCRF specifications, design, develop and validate clinical trial setup in EDC. Review edit check specifications and program edit checks at the trial level. Adaptable to new ways of working using technology to accelerate clinical trial setup.
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Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint.
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Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Prepare, test and implement post production changes as per study needs while ensuring data integrity.
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U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
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Manage and oversee EDC system configuration, EDC Build, and integrations with EDC. Create and own database build SOPs and processes. As the Senior EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies.
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The EDC Engineer maintains and serves as an expert for implementation of EDC best practices and is expected be familiar with leading EDC technologies available on the market. You will continue developing new skills associated with EDC technologies.
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