- 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
- ThermoFisher Scientific (Wilmington, 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),...than one therapeutic area is advantageous.** **Advanced degree(s) (eg, Master or Doctorate) and relevant training or experience (eg,… more
- Parexel (Raleigh, NC)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File ( TMF ) documentation, site reports, ... with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** +… more
- ICON Clinical Research (NC)
- …and escalate issues as soon as identified. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up and ... (SIS) and Informed Consent Forms (ICF): + Prepare, review and approve Global Master ICF templates for Sponsors. + Prepare, review and approve Country Master… more
- Parexel (Raleigh, NC)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File ( TMF ) documentation, site reports, ... with the set-up, running and close-out of sites in a clinical trial . **Monitoring Responsibilities and Study Conduct:** + Ensure proper conduct of clinical… 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)
- …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)
- …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