Manager, Contract and Budget (31797)

Key Responsibilities

• Lead budget negotiations with pharmaceutical sponsors, biotechnology companies, and CROs.
• Develop comprehensive study budgets based on protocol requirements and site capabilities.
• Monitor budget amendments throughout the life of each study.
• Draft, review, negotiate, and manage Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), Master Clinical Trial Agreements (MCTAs), Letters of Intent (LOIs), and related research contracts, coordinating review with legal counsel and other internal stakeholders as needed.
• Track contract status to ensure timely execution and study startup.
• Maintain contract templates and standard operating procedures.
• Ensure contractual obligations are communicated to study teams and monitored throughout study conduct.
• Identify, evaluate, and onboard vendors supporting clinical trial operations.
• Negotiate vendor pricing, scopes of work, service agreements, and payment terms with vendors supporting clinical trial operations.
• Monitor vendor performance, contract compliance, deliverables, and cost effectiveness.
• Coordinate vendor renewals, amendments, and issue resolution.
• Partner with clinical operations, start-up, finance, and regulatory teams to facilitate efficient study startup.
• Ensure contracts, budgets, and vendor agreements align with study timelines and support startup meetings and cross-functional planning.
• Ensure all contracts comply with applicable regulations, institutional policies, and industry standards.
• Identify contractual or financial risks and recommend mitigation strategies.
• Maintain confidentiality of sensitive contractual and financial information.
• Create standardized budget templates, negotiation guidelines, and contract tracking systems.
• Implement best practices to reduce study startup timelines and support continuous improvement initiatives and operational efficiency.
• Review vendor contracting arrangements across sites for optimization and efficiency opportunities.
• Collaborate with investigators, site operations, finance, regulatory, legal, and clinical operations teams.
• Provide education and guidance to research staff regarding contractual and budgetary processes.
• Participate in strategic planning for network growth and sponsor partnerships.

Qualifications

• Bachelor’s degree in Business Administration, Finance, Healthcare Administration, related field, or combination of relevant education and/or experience to equal 6 years.
• 2+ years of experience in clinical research contract and budget negotiation.
• Experience negotiating clinical trial agreements with pharmaceutical sponsors and CROs.
• Experience managing vendor contracts and service agreements.
• Strong understanding of clinical trial startup processes.
• Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
• Advanced proficiency in Microsoft Excel and financial analysis.
• Excellent negotiation, analytical, organizational, and communication skills.