Responsibilities include, but are not limited to:
• Trial and site administration:
o Track (e.g. essential documents) and report
o Ensure collation and distribution of study tools and documents
• Document management:
o Prepare documents and correspondence
o Collate, distribute/ship, and archive clinical documents, e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
• Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up
and submissions
o Obtain, track and update study insurance certificates
• Budgeting, Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop, control, update and close-out country and site budgets (including Split site budget)
o Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators, vendors, grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
• S/AE Claim Management:
Support Financial Clinical Operation Manager(F-COM) for:
o Coordinate meetings
o Update and maintain tracking tools
o Develop and maintain settle agreements
o Coordinate for payments
o Collate, distribute/ship, and archive relevant documents
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.
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