- Parexel (Trenton, NJ)
- …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 (Trenton, NJ)
- …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
- ICON Clinical Research (Blue Bell, PA)
- …site activation, mitigation and action planning. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up ... if assigned on the same studies. + Ensure accuracy and timely completeness of Trial Master File ( TMF ) documents submitted during start-up and perform a… more
- IQVIA (Philadelphia, PA)
- …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
- ICON Clinical Research (Blue Bell, PA)
- …of IP supply activities is provided to clinical trial teams for the Trial Master File . Provides input to drug kit randomization specifications and ... IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator… more
