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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.
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Proven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness. Reporting to the Vice President of Clinical Operations, the Trial Master File (TMF) Associate Director / Director serves a key role, working across the organization for the execution of TMF Operations processes and strategy.
ExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Guides and ensures that the clinical study documentation (documents, images and other digital content) is correctly filed and archived, and that the study is maintained in a trial master file (TMF), so that documentation of GCP compliance is available, if required by a regulatory agency.
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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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Manage site regulatory documents and Trial Master File (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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Works with Study Start‐up and coordinates study start‐up activities including feasibility, investigational product and materials preparation, trial master file set‐ up, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
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Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Experience with all aspects of trial and site startup and vendor management. Drive critical clinical trial activities including trial site activations, recruitment, and database lock.
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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. Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP.
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Conduct or facilitate internal and external audits, includingclinical site, vendor/CRO, Trial Master File, and internal process audits, as needed. Experience with CRO management oversight or experience at a clinical trial site preferred.
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Site activation, training, and trial conduct. Ideally, minimum of 2 years working within an academic clinical trial coordinating center. Manage study portal and access to study documents and trial materials.
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The QA Specialist will have oversight of and involvement in, GMP compliance for production of Clinical Trial Material (CTM), including work performed by Contract Manufacturing Organizations (CMOs.
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You will help to ensure the Trial Master File is up-to-date and inspection ready. As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards.
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Assisting study staff and investigators to effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Experience·Basic Job Description Accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies.
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Provide oversight and quality checks of CRO-managed Trial Master File. Familiarity with ICG/GCP, and FDA requirements governing clinical trial management. Track and reconcile clinical trial equipment, samples, imaging files, etc.
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General Summary/Overview Statement: 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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trial master jobs in Cambridge, MA
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