Trial Capabilities Associate, Budgets

The Trial Capabilities Associate, Budgets & Contracts provides clinical trial capabilities in support of clinical development. The Associate, Budgets & Contracts is accountable to ensure the investigator sites meet requirements to enroll study participants into clinical trials from budgets and contracts perspective and support ongoing budgets and contracts activities during site maintenance and close-out. The Associate, Budgets & Contracts will ensure execution of the budget and contract, and activities related to clinical finance and records management. The Associate, Budgets & Contracts will ensure inspection readiness through contribution to a complete, accurate and readily available Trial Master File. Additional local responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

• Clinical Trial Responsibilities
  • Initiate investigator site activities, including communicate and negotiate budgets and contracts with site personnel, service providers and internal teams, negotiate and obtain fully executed contract, and effectively drive timelines aligned with company priorities
  • Responsible for meeting and exceeding goals for clinical trial initiation for development programs in the region of responsibility
  • Responsible for ensuring site initiation and maintenance activities comply with local/regional requirements, data privacy requirements and Lilly quality standards
  • Communicate directly with sites to enable start-up and maintain an active collaboration with sites regarding budgets and contracts activities during maintenance and close-out
  • Identify, communicate, and resolve issues related to budgets and contracts
  • Ensure country specific regulatory and data privacy requirements are incorporated into budget and contract documents and any other documents/systems
  • Leverage previous site / review board engagements to efficiently drive new work
  • Populate internal systems to ensure accuracy of trial / site performance
  • Understand and comply with procurements, legal and financial requirements and procedures
  • Populate relevant Trial Master Files and libraries for future reference
  • Provide feedback and shared learning for continuous improvement
  • Leverage trial prioritization
  • Anticipate and monitor dynamically changing priorities
    • Clinical Finance Responsibilities
      • Collect and administer financial data from contracting partners and vendors
      • Ensure finance specific requirements are administered in budget and contract documents
      • Ensure internal financial requirements are communicated to contracting partners and vendors
      • Ensure contracting partner and vendor financial requirements are communicated to internally
      • Support contracting partners, vendors and internal stakeholders during the payment process
      • Identify, communicate, and resolve issues related to payments
      Minimum Qualification Requirements
      • Bachelor's degree preferably in a scientific, health related, engineering, economics or project management field, two years clinical research experience (CRO, sponsor or healthcare service provider) or relevant budget and contract negotiation experience preferred
      • Understanding of the overall clinical development paradigm and the importance of efficient site activation
      • Appreciation of / experience in compliance-driven environment
      • Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
      • Effective communication, negotiation, and problem solving skills
      • Self-management and organizational skills
      • Language Capabilities (English and French language)
      Other Information/Additional Preferences
      • Applied knowledge of project management processes and skills preferred

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