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
Job Summary
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.
Assist in study specific submissions document management and document collation for submission, perform document quality and completeness checks, and 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).
Matching Summary
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.
Skills & Requirements
Must-have
CTIS submission management
document collation for submission
submission archiving
CTMS tracking
submission timelines and deliverables
Nice-to-have
integrity in hiring process
honesty and professionalism
Key Requirements
1 year clinical research experience
Equivalent combination of education, training and experience