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 ...