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Ensure the ongoing completeness of the electronic Trial Master File (eTMF). The Senior Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., DM, IRT, and eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development.
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Ensure that all programming and data are conducted in compliance with GCP, relevant SOPs, and regulatory requirements; review and file study documentation in the trial master file (TMF) system acceptable for audit.
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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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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.
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If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. 2 years of clinical research coordinator experience strongly preferred.
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Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. Job OverviewPerform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
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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 / ICH and local regulatory requirements.
$111,972 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Experience with electronic Quality Management Systems and Trial Master File. Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus.
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In collaboration with others on the study management team, ensures the Trial Master File (TMF) remains up to date as well as in compliance with the overall study data quality plan.
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I.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time.
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Conduct reviews of documentation needed for internal and external audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Abiomed internal SOPs, and US and OUS regulations.
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This includes Source Data Validation (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) with the Electronic Trial Master File (eTMF), ensure proper documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.
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Experience in registering essential documents within the Trial Master File. Experience in the clinical drug development process, specifically trial planning and execution practices, including IRB/IEC and Investigator site roles and responsibilities.
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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.
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IQVIA is seeking Senior Clinical Research Associate IIs and Senior Clinical Research Associate IIIs based in the Mid-West, US and Northwest, US. Ideal candidates will have at least 4+ years of on-site monitoring experience.
$111,972 - $174,468 a yearFull-timeExpandApply NowActive JobUpdated Today
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