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Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.
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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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Ensure timely close-out of Pfizer Ignite Studies including decommissioning of data & document sharing platforms, overseeing the transfer of study documents from Pfizer to the CRO/ Vendor Trial Master File (TMF) and final TMF transfer to the Pfizer Ignite Partner.
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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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Texas Health Care Quality Improvement Award of Excellence - TMF Health Quality Institute. Houston Methodist Hospital is affiliated with the Weill Medical College of Cornell University and New York-Presbyterian Hospital, one of the nation's leading centers for medical education and research.
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Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports). Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports.
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Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy. Ensure that CDM documentation is filed into the Trial Master File (TMF) according to SOPs and the study plans; review CDM files for completeness and accuracy.
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TMF Management and Reporting: Handles and maintains electronic TMF and electronic internal repository according to ICH/GCP guidelines and applicable regulations/ standards. Due Diligence: Participates in Due Diligence activities related to TMF. Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.
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Responsible for reviewing TMF filing documents that originate from lab vendors, in accordance with regulatory requirements. Collaborate with the Clinical Development Team in clinical trial sample management including the strategy, planning, and vendor oversight of the processing, tracking, and reconciliation of biomarker, PD, PK, and other types of biological samples, collected for an assigned project.
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Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF.
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The Associate Director, Clinical Records & Information Management will partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP) to ensure timely and quality delivery of the TMF. This role is a member of the Clinical Records leadership team to ensure optimum implementation of the TMF technical capabilities and oversight of standardization, training, quality, and timely clinical trial documentation across the clinical program.
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QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US.
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Focus on compliance, quality, timeliness and accuracy of trial and program deliverables, leveraging clinical expertise, project management and communication skills to ensure compliant, accurate and timely reporting (eg, milestone dates in the Clinical Trial Management System (CTMS), Trial Master File (TMF), Clinical Study Reports (CSR.
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The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team. The TRS is responsible to provide operational expertise to trial teams and Trial Documentation Service (TDS), oversees the implementation of the TMF strategy for the trial and supports the core trial team in all aspects of TMF management, in inspections or audits and in continuous improvement projects.
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The role will serve as the "TMF Archivist" and support trial-specific clinical oversight of the TMF as established within Genmab's procedural documents, GCP-ICH guidelines, and regulatory health expectations during the conduct and closure of the trial.
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