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Trial Master File Records Specialist (TRS) Responsibilities. The TRS will provide services onsite (hybrid position) at our Ridgefield, CT location supporting our Trial Master File (TMF) team.
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Oversee the collection and management of clinical trial documentation to be filed in the Trial Master File (TMF). CTM, Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF.
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You will develop, communicate, and own persona-specific go-to-market plans and product positioning that demonstrate to our customers the value of Medidata's clinical trial financial management solutions, Grants Manager, and Site Payments, as well as our CTMS (Clinical Trial Management System) and eTMF (electronic Master File) solutions.
$135,000 - $180,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Maintain all Data Management documentation to ensure inspection readiness of all Data Management Trial Master File (TMF) documents. Axsome Therapeutics is seeking a Clinical Data Management Specialist to support clinical data management activities in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. This role supports lead data managers, clinical trial managers (CTMs), clinical research associates (CRAs), and clinical trial associates (CTAs) in all data management related activities (i.e. data review and data entries) across multiple programs.
$85,000 - $95,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO’s electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO’s documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.
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Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Reconciles contents of the ISF with the Trial Master File (TMF). Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
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Responsible for implementation and oversight of Trial Master File for inspection readiness. Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements and SOPs.
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Provides oversight for setup, maintenance, and close out of the Trial Master File and ensures its completion and inspection readiness. Candidates must have strong ability to form positive relationships with a variety of team members, including clinical trial Investigators, Study Coordinators, Recruitment Leads, and CRO personnel.
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Ensure archival of all Data Management Trial Master File (TMF) documents. Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings.
$115,000 - $130,000 a yearFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Work in collaboration Global Clinical Operations to maintain the pharmacovigilance section of the Trial Master File/Sponsor Oversight Files to ensure sections related to clinical safety are accurate and up to date.
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Lead the set up and management of the Trial Master File (TMF). Comprehensive understanding of the overall drug development process typically achieved through a Bachelor’s degree in a scientific discipline and 8 years of clinical trial experience in a pharmaceutical, biotech, or a CRO. Advanced degree and multiple years of experience in neurological disorders and/or immunology are differentiators among candidates.
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Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.
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