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Design and develop data capturing tools: Electronic Data Capture (EDC) Systems (Eg: iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF) QC review eg: Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions.
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Assists with filing and management of the Electronic Trial Master File (eTMF) As the In-house CRA you will support and coordinate the logistical aspects of clinical trial management, site management, data review and cleaning according to FDA regulations, Good Clinical Practice (GCP) and relevant SOPs and acts as a pivotal point of contact for the clinical trial team.
ExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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Responsible for development and maintenance of Trial Master File (TMF),3. Sponsor activities include coordinating trial startup and site startup activities, providing training to participating site research staff, regulatory submissions, safety event tracking and reporting, deviation/violation tracking and reporting, participant accrual tracking and reporting, conducting teleconferences, vendor management, coordinating communication with regulatory authorities and manufacturers, etc.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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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). Maintain and audit Trial Master File to ensure inspection readiness.
ExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF). Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG). Direct experience with different Data Management systems and technologies, Clinical Data Management Systems and CDISC data standards.
ExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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Conduct Trial Master File (TMF) audits. Vial is a global tech-driven CRO providing next-generation clinical trial management services. Conduct Trial Master File (TMF) audits.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
$155,000 - $190,000 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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Conduct QA review of clinical protocols, ICFs, Clinical Investigator's Brochure, Clinical Study Report audits and other clinical trial specific documents. Participates in clinical programs and coordinates the cQA interface with Contract Clinical Research Organizations (CROs), Contract Service Providers (CSPs), Bioanalytical Labs and Investigator Sites.
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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.
ExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Maintain complete oversight of eTMF document filing, ensuring accuracy and compliance with company standards, Good Clinical Documentation Practices, and project-level Trial Master File Plan and Index.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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Responsible for review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO. Become an expert in Trial Interactive features and functionality and work with the Director of Clinical Operations.
Full-timeExpandApply NowActive JobUpdated 2 months 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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Close out, final drug accountability and audit readiness of Trial Master File documentation. Fosters a close working relationship with the CDO Trial Data Scientists (TDS) to deliver on clinical study objectives.
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