JobMesh

Associate Director Study Management, Contracts & Budget

AstraZeneca · Gaithersburg, Maryland, US

The Associate Director, Study Management – Contracts and Budget (ADSM C&B) is a member of the global study team and serves as the central operational subject...

Job description

The Associate Director, Study Management – Contracts and Budget (ADSM C&B) is a member of the global study team and serves as the central operational subject matter expert for clinical contracting and study budgets . The role provides end-to-end budget oversight from Clinical Study Protocol (CSP) development through study set up, maintenance, close out, and archiving. The ADSM C&B ensures application of country level Fair Market Value (FMV) at study and country level, maintains the master study and country budgets, and drives timely distribution of approved country budgets to S ite Management and Monito ring /country organizations. As portfolio SME and CSA ( Clinical Study Agreements) POC for SMM and Legal, the role leads ongoing and ad hoc reviews of CSAs and budgets resulting from protocol amendments, ensures a complete, audit ready repository of signed CSAs and related documentation, and aligns cross study and portfolio budgets. The ADSM C&B partners across Study Management, Site Management & Monitoring (SMM), Legal, Procurement, Finance, and if needed external providers to deliver to scope, quality, budget, and timelines in line with ICH GCP, AstraZeneca SOPs, policies, and val...