for and follow-up on site, TMF and systems´ audits and inspections. - Manage the TMF on a site and a country level for regularly...
Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF...
Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential...
on site, TMF and systems ́ audits and inspections.Manage the TMF on a site and a country level for regularly and file...
including forecasting and budgets, oversee vendor oversight and governance, and ensure TMF/eTMF quality....
to final delivery, ensuring quality, timeliness, and TMF-compliant documentation. The role involves developing CST plans...
/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF - May...
), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central...
, coordinate TMF and ISF activities, ensure regulatory submissions, and support site training and vendor coordination. Fluency...
in clinical research, strong English communication, and adept coordination of TMF and site documents across projects....