Regulatory and Start Up Admin

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 submission coordination activities and tracking of submission timelines and deliverables to ensure trial delivery according to agreed upon timelines/milestones.
• 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.
 

Qualifications
• 1 year clinical research experience. Equivalent combination of education, training and experience.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.