Regulatory and Start Up Admin
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Job Location:
Prague - Czech Republic
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
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
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.
Key Skills
- Data Entry
- Adobe Acrobat
- AS400
- EDI
- Microsoft Outlook
- Cloud Architecture
- Microsoft Excel
- Quick Books
- Administrative Experience
- Order Fulfillment
- Project Implementation
- Sales Support
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
