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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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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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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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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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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 global clinical trial operations, in multiple phases of research. Experience with all aspects of trial and site startup and vendor management.
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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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Sanofi is recruiting a new Global medical Director to support post- regulatory authorization clinical trial program for dupilumab in the Global respiratory Franchise for the respiratory indications including asthma and Chronic Obstructive Pulmonary Disease (COPD) for dupilumab and itep.
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The Solution Architect forms strategy on integration, extensions, master data management, reporting / business analytics ensuring effectiveness and cohesion UniFirst's application landscape. Experience integrating Oracle Financial / SCM solutions with 3rd party best in class, master data management solutions, business analytics solutions.
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A PI of the New England Consortium Node of the NIDA Clinical Trials Network (CTN), we are currently leading a major multi-site CTN trial focused on treatment of opioid use disorder. The McLean Hospital Division of Alcohol, Drugs, and Addiction is a highly productive clinical research environment that has led and participated in landmark studies in the field.
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Master Technician: All eight Series A1 thru A8. Master Technician 100% The work environment characteristics described here are representative of those associate encounters while performing the essential functions of the Installation Technician job.
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Oversee eTMF (electronic Trial Master File) creation, maintenance, and archiving, ensuring each are performed in accordance with Standard Operating Procedures (SOP), ICH-GCP Guidelines, EMA, FDA, and other appropriate regulations.
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UBEO Business Services, the premier provider of business technology products and services, is seeking to hire an Field Service Master Tech to join our team. Associate Degree or equivalent technical training.
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The Sr Business Analyst (BA), Master Data Management (MDM) acts as an intermediary between the business and technical community. The Sr BA will work with IT project teams and business clients within all areas of the master data community to collect, clarify, and translate business requirements into documentation.
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Beam is seeking a highly energetic flow cytometry expert to join our team as a Research Associate/Senior Research Associate to evaluate lead candidate cell therapies for the treatment of Hematological and Immunological diseases.
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trial master file jobs Title: research associate Company: Parexel in Lexington, MA
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