- Sumitomo Pharma (Raleigh, NC)
- …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 (Durham, NC)
- …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
- ThermoFisher Scientific (Greenville, NC)
- …and review (including appendices) + Collect/review/ File study documents in support of the trial master file ( TMF ) + Collect/review/ File study ... may include but are not limited to PTA (Post Trial Access), RATIO (R&D Asset Transition and Integration Office),...and vendors are appropriately onboarded + Identifies and oversees trial risk and mitigation + Leader of the cross… more
- IQVIA (Durham, NC)
- …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 (Durham, NC)
- …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 (Durham, NC)
- …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