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Collect, file, and track clinical trial associated study and regulatory documents for the Trial Master Files. Maintenance of the Trial Master File and/or electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
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Manage set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness. Oversee the clinical trial insurance process, track approvals, revisions, and renewals of certificates.
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Assists in the development and maintenance of a detailed schedule of QA/Reg milestones and deliverables; to include internal audits, quality improvement projects, Trial Master File (TMF) reconciliations, etc.
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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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Master Access Files (MAF), eMDR reporting, 510(k), EU Tech File and De Novo Filings a plus. Work with Product Development, Marketing, Clinical Operations, and other departments as needed to ensure that all product labeling, instructional and promotional materials are in compliance with regulatory requirements.
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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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Responsible for development and maintenance of Trial Master File (TMF) The Division of Rheumatology, Allergy and Immunology (DRAI) at Massachusetts General Hospital (MGH) is seeking an intellectually curious and highly organized individual with supervisory experience to serve as a Research Project Manager in a clinical trial which will test two different treatment strategies for gout.
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The research nuclear medicine technologist (RNMT), working under the general supervision of the study Principal Investigator and the Research project Manager provides coordination for designated clinical trial activities in Nuclear Cardiology.
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Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF. Experience with global clinical trial operations, in multiple phases of research.
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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.
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The Talend ETL Developer is a key member of CHIA’s software development organization and our Data Operations and Technology team reporting to the Associate Director of Master Data Management and ETL Design.
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The Legal Chief of Staff advises the Commissioner and the Probation Service on a variety of matters, including the formulation, development and review of Probation policies, procedures and protocols, and Probation-related legislation, regulations, and standards; provides counsel on human resources, labor and disciplinary matters consistent with overarching Trial Court policy.
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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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Reporting to the Associate Director of Clinical Operations, this individual will have primary responsibility for trial management within in vivo, regenerative medicine, or oncology indications.
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The Bioinformatics Scientist is responsible for analyzing antibody selection data from yeast display, implementing machine learning algorithms to enhance data analysis and lead selection, and managing the data pipeline from raw file processing to database storage.
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trial master file jobs Title: clinical research associate Company: Parexel in Somerville, MA
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