Study Start Up Associate I/II

•     *Responsible   for  the   translation   and  co-ordination   of   translations   for  documents  required   for submission (if applicable for region).

•     *Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system.

•     *Copy and route incoming correspondence, internal documentation, etc., as appropriate.

•     *Responsible for the timely follow-up for queries made by CNEC.

•     *Responsible for the collection of critical documents required for IP Release.

•     Attend study team meetings as required.

•     Assemble  and distribute study  materials  to Clinical and  Project teams,  including  materials  to  study sites and Investigator Meetings (e.g.; investigator binders) and vendors, as appropriate.

•     *Be familiar with  ICH GCP, relevant country regulations/guidelines and ICON SOPs.

•     Assist  and  provide  support  to  the  Study  Start  Up  Lead  to ·    maximize  submission  effectiveness, minimize timelines and ensure sponsor satisfaction.

•     Undertake other reasonably  related duties as may be assigned from time to time.