Project Manager (Argentina)
.May assist the project manager II with quality reviews and or audits of the Trial Master File (TMF) to ensure inspection...
.May assist the project manager II with quality reviews and or audits of the Trial Master File (TMF) to ensure inspection...
required study‐specific CDS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. Ensure...
progress, and issue escalation.Maintain oversight of study documentation, including TMF quality, CTMS accuracy, monitoring...
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...
(TMF) to ensure inspection readiness. May support clinical monitoring activities, such as CRA training, visit report...
-up on site, TMF and systems´ audits and inspections. Manage the TMF on a site and a country level for regularly and file...
-up on site, TMF and systems´ audits and inspections. Manage the TMF on a site and a country level for regularly and file...
of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF and reconciling TMF documentation...
of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF and reconciling TMF documentation...
applicable regulations Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study... specific plans in the relevant TMF May support the clinical team performing Pre-Study Site Visits May participate/support...