- Sumitomo Pharma (Sacramento, CA)
- …information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Trial Master File ( TMF ) Specialist will be ... for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits...overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF… more
- IQVIA (Carlsbad, CA)
- …and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (eg, Trial Master File ( TMF )) that track site compliance ... * Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. * Assist with the tracking and… more
- Gilead Sciences, Inc. (CA)
- …teams, Clinical Research Organizations (CROs), and Functional Service Providers (FSPs) to ensure Trial Master File ( TMF ) compliance with industry ... for inspection readiness and audit/inspection preparation + Ensure standardized TMF practices across clinical trial teams +...TMF within the pharmaceutical/biotech industry experience OR + Master 's and 8+ years of compliance and TMF… more
- IQVIA (Carlsbad, CA)
- …start-up phase. + Document Management: Ensure site documents are available for filing in the Trial Master File ( TMF ) and verify that the Investigator's ... Management: If applicable, manage site financials according to the clinical trial agreement and retrieve invoices as required by local regulations.… more
- IQVIA (San Francisco, CA)
- …start-up phase. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) and verify that the ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Education:… more
- IQVIA (Carlsbad, CA)
- …phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File ( TMF ) verify that the Investigator's Site ... be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications *… more
- IQVIA (Carlsbad, CA)
- …Support start-up phases as required. Documentation: Ensure all site documents are filed in the Trial Master File ( TMF ) and Investigator's Site File ... Associate! You'll play a pivotal role in monitoring and managing clinical trial sites to ensure compliance with study protocols, regulations, and sponsor… more
- IQVIA (San Francisco, CA)
- …of data queries. + Ensure that essential documents are collected and maintained in both the Trial Master File ( TMF ) and the Investigator Site File ... (ISF) in accordance with regulatory standards. + Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. + Work closely with cross-functional project teams to support study execution and ensure… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file ( TMF ). + Maintains compliance with ... ERP system. Has good understanding and working knowledge in master data management. + Data and analytics: oversees the...Doctorate and 2+ years of Industry experience OR + Master 's and 6+ years of Industry experience OR +… more
- Cordis (Irvine, CA)
- …study tasks from start-up phase through study completion + Maintain internal Trial Master Files (TMFs) and prepare study TMF for audit readiness + Assist in ... that address unmet and critical medical needs. **Responsibilities** We are seeking a Clinical Trial Associate in Irvine, CA to join our clinical study team in the… more
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