CRA SSU with at least 2 years of regulatory experience - Sponsor dedicated - Argentina Client Based
updated accordingly and ensures timesheet compliance. Ensure all relevant documents are submitted to the Trial Master File (TMF...
updated accordingly and ensures timesheet compliance. Ensure all relevant documents are submitted to the Trial Master File (TMF...
study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines...
in clinical research, strong English communication, and adept coordination of TMF and site documents across projects. #J--Ljbffr...
preparation for and follow-up on site, TMF and systems´ audits and inspections. - Manage the TMF on a site and a country level...
forecasting and budgets, oversee vendor oversight and governance, and ensure TMF/eTMF quality. #J--Ljbffr...
for achievement to plan. Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up... and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF. Attend study team meetings...
performance and integration with HPE NonStop systems. Understand and support HPE NonStop subsystems (Mediacom, TMF, KMSF... servers and integrating them with HPE NonStop systems. Strong understanding of HPE NonStop subsystems (Mediacom, TMF, KMSF...
forecasting and budgets, oversee vendor oversight and governance, and ensure TMF/eTMF quality. #J--Ljbffr...
(ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures...
documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously to support downstream inspection...