Overview
The Manager, Contracts & Budgets supports the review and negotiation of awarded clinical trial budgets and contracts, including any follow-on amendments. This role works with outside legal counsel to negotiate Clinical Trial Agreement contracts to ensure the language meets market expectations and protects the organization. Budget negotiations use historical data, input from site leaders, and budget justification letters. The role also maintains current tracking documents that detail the status of each contract, budget, or amendment and shares this information across the organization.
Responsibilities
- Develop, negotiate, and finalize study budgets from initial awareness through the live contract phase
- Analyze clinical trial protocols to identify requirements and assign dollar amounts based on study specifics
- Collaborate with internal teams to create competitive budgets that maximize financial return, using available budget tracking and management tools
- Negotiate budget-related contract terms and specific budget line items with sponsors, CROs, and other stakeholders via spreadsheets, emails, and meetings
- Track and analyze budget performance throughout the study lifecycle, adjusting as needed to maintain profitability
- Collaborate with legal and clinical operations teams to support accurate and timely execution of contracts and agreements
- Verify that all necessary budgetary information is included in executed contracts to prevent financial discrepancies
- Serve as a point of contact for budget-related or contract questions and issues raised by sponsors, CROs, or internal teams
- Support audit and inspection readiness, including participation in sponsor audits, regulatory inspections, and internal quality reviews
- Complete required SOP training and organization-required trainings as assigned and when updated
- Maintain required licenses and certifications and ensure they remain current and in good standing
- Travel to company meetings, site locations, or study-related activities as required
- Perform other duties as assigned
Requirements
- Bachelor’s degree in finance, business administration, or a related field preferred, or an equivalent combination of education and experience
- Minimum of 2 years of experience in clinical research budget development and contract negotiation
Systems & Technology
- Spreadsheet software (Excel)
- Word processing software (Word)
- Electronic mail software (Outlook)
- Presentation software (PowerPoint)
- Experience with EDC systems (e.g., Medidata Rave, REDCap)
- Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Veeva)
Other Skills
- Fluency in Spanish is preferred
- Ability to read, analyze, and interpret clinical trial protocols to identify financial requirements
- Experience negotiating clinical trial budgets and Clinical Trial Agreements with sponsors and CROs
- Strong financial acumen and analytical thinking
- Working knowledge of regulatory and compliance requirements related to clinical trial agreements
- Strong attention to detail and accuracy
- Ability to manage multiple tasks and priorities
- Strong organizational and time management skills
- Ability to work independently and as part of a team
- Effective communication and interpersonal skills
- Ability to maintain confidentiality and professionalism
- Strong problem-solving and critical thinking skills
- Ability to adapt to changing priorities
- Ability to exercise sound judgment and decision-making
- Customer service mindset with focus on patient experience
- Ability to follow protocols, SOPs, and regulatory requirements
- Ability to handle high-pressure or fast-paced environments
Compensation & Benefits
Not specified.
Location
Not specified.
Physical Requirements and Environmental Factors
- Continually required to stand
- Frequently required to walk
- Continually required to sit
- Continually required to utilize hand and finger dexterity
- Occasionally required to climb, balance, bend, stoop, kneel, or crawl
- Continually required to talk or hear
- Noise level in the work environment is usually moderate
- Occasionally lift and/or move up to 20 pounds
- Specific vision abilities required:
- Close vision
- Distance vision
- Color vision
- Peripheral vision
- Depth perception
- Ability to adjust focus