Manager, Contracts & Budgets in at Empathx Clinical Research

Position Summary: The Manager, Contracts & Budgets supports Empathx Clinical Research in the review and negotiation of awarded clinical trial budgets and contracts and any follow-on amendments, working with outside legal counsel to negotiate Clinical Trial Agreement contracts to ensure language meets market expectations and protects Empathx. Clinical trial budgets are negotiated using historical data, input from site leaders, and budget justification letters. This role keeps current tracking documents detailing the status of each contract, budget, or amendment and shares this information across the organization.

Duties and Responsibilities:

• Develop, negotiate, and finalize study budgets from initial awareness to the live contract phase
• Analyze clinical trial protocols to identify the requirements and accurately assign dollar amounts based on study specifics
• Collaborate with internal teams to create competitive budgets that maximize financial return for the company, utilizing available tools for budget tracking and management
• 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 lifecycle of a study, adjusting as needed to maintain profitability
• Collaborate with legal and clinical operations teams to facilitate accurate and timely execution of contracts and agreements
• Verify that all necessary budgetary information is included in executed contracts, preventing any financial discrepancies
• Act as a point of contact for any budget-related or contracts questions or 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 all required SOP training and company-required trainings as assigned and when updated
• Maintain all 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

This job description is not intended to be an exhaustive list of all duties or responsibilities associated with the position. The Company reserves the right to modify this job description at any time.

Qualifications:

• Bachelor's degree in finance, business administration, or a related field preferred, or equivalent combination of education and experience.
• Minimum of 2 years of experience in clinical research budget development and contract negotiation
• Certificates, licenses and registrations required:
• Systems & Technology skills required:
  • 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 required:
  • 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

Physical Requirements and/or 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.
• While performing the duties of this job, the noise level in the work environment is usually moderate
• The employee must
  • Occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required by this job include:
  • Close vision
  • Distance vision
  • Color vision
  • Peripheral vision
  • Depth perception
  • Ability to adjust focus