- Parexel (Salt Lake City, UT)
- …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
- Sumitomo Pharma (Salt Lake City, UT)
- …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
- Parexel (Salt Lake City, UT)
- …as required by local laws/guidelines. + Ensures all relevant documents are submitted to the Trial Master File ( TMF ) + Responsible for liaising with ... assigned country eg, IRAS + Responsible for ensuring clinical trial insurance is in place for submission. + Responsible...Vendor, and Regulatory Lead to enable a rapid clinical trial start up. + Inform team members of completion… more
- IQVIA (Salt Lake City, UT)
- …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
