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Strong understanding of the Trial Master File structure (TMF) Special skills/knowledge Highly proficient using the Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Adobe) Knowledge in additional applications Good written and verbal communication skills and proven ability to multitask.
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Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’ Biomarker operations, oncology, clinical trial operations, project management.
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Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained. Prior experience working with high-complexity CLIA or CAP certified/accredited/ laboratories conducting clinical trial testing.
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Exceptional knowledge of EC/IRB regulations, regulatory document requirements, expectations, and monitoring of the Trial Master File (TMF). The Senior Clinical Research Associate (Sr. CRA) is an integral member of the clinical study team, effectively managing multiple priorities to ensure study subject safety, and successful data collection and integrity of the clinical trial.
$138,500 - $153,100 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Leads and/or participates in the development and review of study documents including CRF design, project plans, Service Provider Oversight plans, TMF (Trial Master File) plan. Manages study sites and study related activities including but not limited to site feasibility, selection, start up, subject recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review / clean up.
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Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF); This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace.
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To collect all essential documents required before the site begins to screen patients to participate in the clinical trial; 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry specializing in study start-up is required.
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Ensures Trial Master File (TMF) is maintained throughout the study and helps with periodic TMF QC/audits. Minimum 2-4+ years of clinical trial management experience working for a Sponsor company, CRA/field monitor, or CRO setting.
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Oversee the development and maintenance of the Trial Master File (TMF), ensuring regular TMF audits and a final TMF that is complete and inspection-ready. Manage the trial in accordance with SOPs, GCP/ICH guidelines and all applicable laws and regulations.
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Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation.
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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.
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Ensure the availability of site documents for filing in the Trial Master File (TMF) and verify maintenance of the Investigator's Site File (ISF) in accordance with GCP/ICH and local regulatory requirements.
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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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Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
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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
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