Associate Director Study Management, Contracts & Budget

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 setup, maintenance, closeout, 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 Site Management and Monitoring /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 values. You may be based in Gaithersburg, MD or Waltham, MA and will report to the Director, Study Management Cell Therapy.

Accountabilities

• Contracts and budget strategy and oversight: Set up and lead the end-to-end operational strategy for study contracting and budgeting across assigned studies and programs, aligning with CSP, country requirements, bio sampling plans, and funding envelopes. Serve as the single point of accountability for budget integrity and contract alignment from concept to closeout, to the end of operational strategy for study contracting and budgeting across assigned studies and programs, aligning with CSP, country requirements. 

• FMV governance and application: Ensure country level FMV benchmarks are established, current, and consistently applied across study and country budgets, including sites, central/specialty labs, and other vendors. Document FMV methodologies, justifications, and deviations in accordance with compliance and regulations. Level FMV benchmarks are established, current, and consistently applied across study and country budgets, including sites, central/specialty labs, and other vendors. Document FMV methodologies, justifications, and deviations in accordance with compliance and antikickback regulations. 

• Master study and country budgets and CSA templates: Build, maintain, and own the master study and country budget and CSA templates; perform scenario modelling and sensitivity analysis based on study design changes, enrolment dynamics, and operational assumptions. 

• Budget and CSA distribution to countries: Finalize and distribute approved country budgets to SMM/country teams with clear negotiation guidance, parameters, and change control rules. Track implementation and provide clarification during site negotiations as needed. Maintains country study templates and adjusting changes in due course of the study as needed. 

• CSA subject matter