Director

Description:

The Clinical Site Budget Management Director within Global Clinical Business Operations oversees the development, payments, and analytics of all global site budgets. The Director is responsible for managing the financial aspects of clinical trial study sites, including the creation of site budgets, overseeing payments, and providing detailed analytics. This role ensures that all financial activities related to clinical sites are executed efficiently and in compliance with regulatory requirements, company policies, and industry standards

Essential Functions:
 

• Site Budget Development & Estimation
• Develop and negotiate clinical site budgets in alignment with protocol scope, market conditions, and corporate goals.
• Utilize historical data, benchmarks, and financial tools (e.g., Grants Plan) to create accurate cost estimates.
• Create budget templates, define negotiation parameters, and finalize budgets across assigned studies.
• Budget Negotiation
• Support and lead budget negotiations with sites and CROs, providing clear rationale for all line items.
• Collaborate with study teams to resolve disputes, escalating as needed.
• Track communications, amendments, and negotiation outcomes while maintaining alignment with financial objectives.
• FMV, Compliance & Documentation
• Ensure compliance with GCP, FDA, FMV, transparency regulations, and internal policies.
• Maintain accurate and complete documentation of all budgets, contracts, and payment activities.
• Support audits, inspections, and quality assurance reviews.
• Clinical Trial Agreements (CTAs)
• Partner with Legal to draft, negotiate, and finalize CTAs, including budgets and payment terms.
• Serve as the first point of contact for CTA-related financial queries.
• Support the management and improvement of Kyowa Kirin’s contract database.
• Site Payments Management
• Oversee timely and accurate site payments, ensuring adherence to contracts and regulatory standards.
• Manage payment schedules, resolve discrepancies, and support reconciliation with CROs and third-party vendors.
• Act as subject matter expert and escalation point for site payment processes.
• Financial Analysis & Reporting
• Deliver financial analysis, forecasts, and regular reporting on site budgets and payments.
• Use analytics tools to identify trends and support data-driven decision-making.
• Prepare reports and presentations for senior leadership and key stakeholders.
• Stakeholder Collaboration
• Collaborate with investigators, site staff, CROs, and internal teams (Clinical Operations, Project Management, Finance, Legal) to ensure smooth financial operations.
• Serve as the primary contact for all site budget-related inquiries.
• Build and maintain strong cross-functional relationships to align financial strategies.
• Process Improvement
• Identify and implement best practices to streamline budget development, payment processes, and financial reporting.
• Monitor industry trends and regulatory changes to enhance compliance and efficiency.
• Introduce innovative solutions to improve accuracy and timeliness of financial operations.
  
   

Requirements:

Education

Bachelor’s degree in finance, Accounting, Business Administration, or closely related discipline. An advanced degree or relevant certification (e.g., CPA, CFA) is preferred.

Experience

At least 10+ years of experience in clinical trial budgeting, financial management, or a related area within the pharmaceutical or biotech industry.