Manager, Contract and Budget (31797) in Austin, Texas at GI Alliance
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Job Description
Job DetailsJob Location: Urology Austin Atrium - Austin, TX 78759
Position Type: Full Time
Job Shift: Day
Description
Contract & Budget Manager
Position Summary:
The Contract & Budget Manager is responsible for the development, negotiation, and management of clinical trial budgets, sponsor contracts, and vendor agreements across a multi-site research network. This position serves as the primary liaison between sponsors, contract research organizations (CROs), research sites, and internal stakeholders to ensure timely contract execution, accurate budgeting, compliance, financial viability and feasibility, and effective vendor oversight. The role requires strong financial, contractual, and operational expertise to support the successful startup and execution of clinical research studies while optimizing financial performance across the network.
Key Responsibilities:
Lead budget negotiations with pharmaceutical sponsors, biotechnology companies, and CROs.
Lead budget negotiations with pharmaceutical sponsors, biotechnology companies, and CROs.
Develop comprehensive study budgets based on protocol requirements and site capabilities.
Develop comprehensive study budgets based on protocol requirements and site capabilities.
Monitor budget amendments throughout the life of each study.
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.
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.
Track contract status to ensure timely execution and study startup.
Maintain contract templates and standard operating procedures.
Maintain contract templates and standard operating procedures.
Ensure contractual obligations are communicated to study teams and monitored throughout study conduct.
Ensure contractual obligations are communicated to study teams and monitored throughout study conduct.
Identify, evaluate, and onboard vendors supporting clinical trial operations.
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.
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.
Monitor vendor performance, contract compliance, deliverables, and cost effectiveness.
Coordinate vendor renewals, amendments, and issue resolution.
Coordinate vendor renewals, amendments, and issue resolution.
Partner with clinical operations, start-up, finance, and regulatory teams to facilitate efficient study startup.
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 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.
Ensure all contracts comply with applicable regulations, institutional policies, and industry standards.
Identify contractual or financial risks and recommend mitigation strategies.
Identify contractual or financial risks and recommend mitigation strategies.
Maintain confidentiality of sensitive contractual and financial information.
Maintain confidentiality of sensitive contractual and financial information.
Develop and improve contract and budget workflows across the research network.
Develop and improve contract and budget workflows across the research network.
Create standardized budget templates, negotiation guidelines, and contract tracking systems.
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.
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.
Review vendor contracting arrangements across sites for optimization and efficiency opportunities.
Collaborate with investigators, site operations, finance, regulatory, legal, and clinical operations teams.
Collaborate with investigators, site operations, finance, regulatory, legal, and clinical operations teams.
Provide education and guidance to research staff regarding contractual and budgetary processes.
Provide education and guidance to research staff regarding contractual and budgetary processes.
Participate in strategic planning for network growth and sponsor partnerships.
Participate in strategic planning for network growth and sponsor partnerships.
Qualifications
Qualifications
Bachelor’s degree in Business Administration, Finance, Healthcare Administration, related field, or combination of relevant education and/or experience to equal 6 years.
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.
2+ years of experience in clinical research contract and budget negotiation.
Experience negotiating clinical trial agreements with pharmaceutical sponsors and CROs.
Experience negotiating clinical trial agreements with pharmaceutical sponsors and CROs.
Experience managing vendor contracts and service agreements.
Experience managing vendor contracts and service agreements.
Strong understanding of clinical trial startup processes.
Strong understanding of clinical trial startup processes.
Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
Knowledge of FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
Advanced proficiency in Microsoft Excel and financial analysis.
Advanced proficiency in Microsoft Excel and financial analysis.
Excellent negotiation, analytical, organizational, and communication skills.
Excellent negotiation, analytical, organizational, and communication skills.