Project Manager (Argentina)
(TMF) to ensure inspection readiness. May support clinical monitoring activities, such as CRA training, visit report...
(TMF) to ensure inspection readiness. May support clinical monitoring activities, such as CRA training, visit report...
of study documentation, including TMF quality, CTMS accuracy, monitoring plans, training plans, and study‑specific materials...
escalation. - Maintain oversight of TMF quality, CTMS accuracy, and study documentation. - Partner with the Project Manager...
(ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures...
with regard to maintenance of TMF and eTMF Quality Control - Database QC checks performance and documentation - Shared...
for and follow-up on site, TMF and systems audits and inspections.Manage the TMF at site and country levels on a regular basis...
study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines...
and dispositions. - Coordinate preparation for and follow-up on site, TMF and systems audits and inspections. - Manage the TMF...
team members to ensure Trial Master File (TMF) set up meets study requirements, and maintains oversight of TMF completeness... documents to TMF and maintains oversight of Investigator Site File (ISF) reconciliation and completeness actions - Provides...
), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team...