Senior Manager, Contracts

ICON plcPhiladelphia, PA

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. This Senior Manager, Contracts role is responsible for setting up and leading the end-to-end operational strategy for study contracting and budgeting across assigned studies and programs. The position ensures alignment with CSP, country requirements, biosampling plans, and funding envelopes, serving as the single point of accountability for budget integrity and contract alignment from concept to closeout. Key responsibilities include establishing and applying country-level Fair Market Value (FMV) benchmarks, building and maintaining master study and country budget and Clinical Study Agreement (CSA) templates, and distributing approved country budgets with clear negotiation guidance. The Senior Manager acts as a subject matter expert for CSAs, guiding terms and rate structures, leading impact assessments for protocol amendments, and ensuring timely maintenance and distribution of all contracting documentation. The role also involves cross-functional leadership, collaboration with various teams (Study Teams, SMM, Legal, Procurement, Finance, scientific functions), and driving process improvement and standardization in contracting and budgeting operations.

Requirements

  • University degree (or equivalent).
  • At least 5 years of relevant clinical experience in the pharmaceutical industry focused in Budgets/Contracts, including 2 years of operational strategy 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 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.

Nice To Haves

  • University degree preferably in medical or biological sciences or a discipline associated with clinical research.

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, biosampling plans, and funding envelopes.
  • Serve as the single point of accountability for budget integrity and contract alignment from concept to closeout.
  • 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.
  • 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.
  • 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.
  • 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.

Benefits

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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