Regulatory and Start Up Admin
Employer · IQVIA
Licensing officer
Administrative assistantOffice clerkFull-timeBudapest
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.
Tasks
- 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).
- Support submission coordination activities and tracking of submission timelines and deliverables.
- Responsible for review/management of CTIS for completeness and timely entry of information into CTIS.
- Assist CTSC, Regulatory CTA SM, CTM and GTL with applicable CTIS support.
- Provide overview of submission/substantial amendment/notification management metrics as needed.
Requirements
- 1 year clinical research experience. Equivalent combination of education, training and experience.