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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.
Full-timeExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
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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.
Full-timeExpandApply NowActive JobUpdated 28 days ago - UpvoteDownvoteShare Job
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Perform ongoing review of study documentation in the trial master file (TMF) to always ensure audit readiness. The individual must have a good understanding of and substantial experience with clinical trial guidelines and procedures such as ICH-GCP, 21 CFR part 11 and CDISC. The position will be responsible for preserving data integrity and adhering to timelines for regulatory submissions and publications.
Full-timeExpandApply NowActive JobUpdated 19 days ago - UpvoteDownvoteShare Job
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Conduct internal audits to assess effectiveness of Entrada's GCP/GLP QMS and process compliance including Clinical Study Report (CSR) and Trial Master File (TMF) audits. Collaborate and provide QA expertise in processes such as investigations, corrective and preventive action (CAPA) plans, trial protocol deviations, complaints, risk management, risk assessments, recalls, safety events/reporting, relevant regulatory submission sections, and trial documentation review.
Full-timeExpandApply NowActive JobUpdated 2 months ago - UpvoteDownvoteShare Job
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Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) The GSM ensures alignment across the study team functions to ensure delivery of study milestones and ensures milestones and study goals are aligned with those of the project team and Trial Operations.
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Experience with various clinical trial systems (EDC, CTMS, TMFs) trial master file organization, regulatory documents required. · Organizes, manages, reviews and in cases where this is outsourced, oversees the Trial Master File to maintain up-to-date regulatory documentation for all research sites.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
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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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Identifies and supports the DSPV team with document management activities (e.g., electronic Trial Master File, Veeva), including maintaining electronic files internally, and collaborate cross- functionally with Client teams, CRO’s and vendors.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
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Prepares/oversees the preparation of all applicable documents required for the conduct of the study (Project Plan, Risk Management Plan, Monitoring Plan, Trial Master File (TMF. Ensure the TMF is set up and maintained appropriately throughout the trial, including periodic reviews.
Full-timeExpandApply NowActive JobUpdated 4 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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The Associate Director, Clinical Operations (TMF, CTMS) is responsible for managing the day-to-day operations of important clinical systems (Trial Master File and Clinical Trial Management) that support clinical trial execution.
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Collect, review and approve all required regulatory documents; and work to ensure the study Trial Master File (TMF) is up to date and “audit ready” throughout the course of the study.
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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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Takeda Development Center Americas, Inc. is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements: Master's degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience.
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trial master file jobs in Cambridge, MA
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