Job Overview

Perform tasks in support of the Clinical Trial Submission Coordinator (CTSC), Regulatory CTA SM and GCO country teams to make all clinical trial initial submissions, clinical trial amendment submissions and clinical trial notifications in CTIS and track the progress of submissions/notifications.

Essential Functions
• Assist in study specific submissions document management and document collation for submission
• Perform document quality and completeness checks
• Transfer submission package to CTIS, make submission in CTIS and perform submission archiving.
• Ensure the current submission status and tracking of related information is always available in the appropriate clinical trial management system(s) (CTMS). Work with CTSC, Local Trial Managers and Site Managers, GCO country Local Submission Coordinator, CRO to ensure submissions data are up-to-date, complete, and accurate during all phases of the trial
• Support subm...