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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