Associate Director, Functional Service Partnership (FSP), Site Contracts

Work Schedule

Environmental Conditions

Job Description

Role Description:

The Associate Director Functional Service Partnership (FSP) Site Contracts is a full FTE member of the global study team for a Sponsor and serves as the central operational subject matter expert for clinical contracting and study budgets. The role provides endtoend budget oversight from Clinical Study Protocol (CSP) development through study setup maintenance closeout and archiving. The FSP SITE CONTRACTS AD ensures application of countrylevel 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) pointofcontact (POC) for Sponsor Study Management & Monitoring and Sponsor Legal the role leads ongoing and ad hoc reviews of CSAs and budgets resulting from protocol amendments ensures a complete auditready repository of signed CSAs and related documentation and aligns crossstudy and portfolio budgets. The FSP SITE CONTRACTS AD 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 Sponsor SOPs policies and values.

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 biosampling plans and funding envelopes. Serve as the single point of accountability for budget integrity and contract alignment from concept to operational strategy for study contracting and budgeting across assigned studies and programs aligning with CSP country requirements out.
• 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 expertise: 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 appendices and change orders; coordinate review cycles and approvals to meet startup timelines.
• Protocol amendment impact assessment: 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.
• Documentation ownership and repository management: 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 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.
• Cross-functional leadership and collaboration: 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 leadership and collaborationmaking resolve issues and drive alignment on budget and contract priorities and timelines.
• Process improvement and standardization: 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 solutions; lead or contribute to continuous improvement and change initiatives impacting contracting and budgeting operations.
• Training and enablement: 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 teams on budget/CSA processes FMV application and change control; collect and share lessons learned and best practices.

Required Education Qualifications Skills and Experience:

• University degree (or equivalent)
• At least 5 years of relevant clinical experience in the pharmaceutical industry including 2 years of site budget and contracts oversight/project management experience.
• 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 oversight/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.
• Fluent verbal and written English.