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