Associate Director Study Management, Contracts & Budget

AstraZeneca•Gaithersburg, MD

20h•$137,000 - $206,000•Hybrid

About The Position

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.

Requirements

Bachelor's degree, preferably in medical or biological sciences or a discipline associated with clinical research.
At least 5 years of relevant clinical experience in the pharmaceutical industry, including 2+ years of project management experience on a global level.
Extensive knowledge of clinical research regulatory requirements; excellent understanding of ICH/GCP, and study management processes, including contracting and study budget management.
Strong leadership and cross-functional collaboration skills with demonstrated ability to influence without authority and coordinate complex workstreams across scientific and operational functions.
Proven project management skills, including planning, risk management, timeline and budget oversight; proficiency with standard project tools and IT systems.
Excellent communication, stakeholder management, and relationship-building skills; strong negotiation and conflict management capabilities.
Strong organizational and problem-solving skills; ability to manage competing priorities and maintain attention to detail.

Nice To Haves

Advanced degree preferred.
Project management certification
Experience in all phases of a clinical study lifecycle
Proficiency in Microsoft Project and Falcon system
Basic change management skills
Team oriented and flexible

Responsibilities

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.
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.
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.
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.
Act as portfolio SME and primary POC for Clinical Study Agreements (CSAs) with SMM and Legal.
Guide terms, rate structures, study specific appendices, and change orders; coordinate review cycles and approvals to meet startup timelines, specific appendices, and change orders; coordinate review cycles and approvals to meet startup timelines.
Lead ongoing and ad hoc CSA and budget reviews triggered by protocol amendments or operational changes.
Quantify impacts, secure approvals, adjust master and country budgets, and execute contract amendments in a timely and compliant manner.
Ensure timely maintenance and distribution of contracting documentation, including a complete, version-controlled repository of signed CSAs, amendments, rate cards, and budget approvals across the portfolio; ensure eTMF completeness and inspection readiness; controlled repository of signed CSAs, amendments, rate cards, and budget approvals across the portfolio; ensure eTMF completeness and inspection readiness.
Partner with Finance on forecasting, risk/opportunity management, and governance reporting, if needed.
Coordinate deliverables across Study Teams, SMM, Legal, Procurement, Finance, and scientific functions; facilitate decision making, resolve issues, and drive alignment on budget and contract priorities and timelines; functional leadership and collaboration making, resolve issues, and drive alignment on budget and contract priorities and timelines.
Establish and refine standards, templates, guidance, and tools for budgets and CSAs; identify opportunities for automation and AI enabled solutions; lead or contribute to continuous improvement and change initiatives impacting contracting and budgeting operations enabled solutions; lead or contribute to continuous improvement and change initiatives impacting contracting and budgeting operations.
Provide targeted training to Study Management, SMM, and cross functional teams on budget/CSA processes, FMV application, and change control; collect and share lessons learned and best practices to functional teams on budget/CSA processes, FMV application, and change control; collect and share lessons learned and best practices.