Clinical Trial Contracts & Budget Lead, Remote

Overview

This role is responsible for performance and compliance for assigned protocols in a country in accordance with ICH/GCP and applicable country regulations, as well as organizational policies, procedures, quality standards, and adverse event reporting requirements (internally and externally).

Under the oversight of the Sr. Clinical Operations Manager (COM), Head COMs, or Therapy Area Heads (TAH), this position supports the preparation, analysis, negotiation, and revision of clinical research contracts and budgets throughout the full contract lifecycle.

Responsibilities

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets, including:
  • Clinical Trial Research Agreements (CTRA)
  • Master Clinical Trial Research Agreements (MCTRA)
  • Confidentiality Disclosure Agreements (CDA)
  • Multiple Confidentiality Disclosure Agreements (MCDA)
  • Imaging Research Allocation Grid (IRAG)
  • Master Fee Schedules (MFS)
  • Facility Use Agreement (FUA)
  • Reimbursement Letters
  • Amendments and Assignments
• Use legal fallback language, budget parameters, and escalate site-specific issues that do not comply with established guidelines for review and approval
• Maintain databases and files for contracts, approvals, and budgets using uniform naming and savings conventions
• Track required documents and metrics to ensure timely execution of site agreements
• Perform quality control checks of agreements prior to execution
• Coordinate and liaise with Clinical Research Manager (CRM), Clinical Trial Coordinator (CTC), Clinical Research Associate (CRA), and Clinical Operations Manager - Regulatory (COM-R) (including Finance/Legal as appropriate) to support Site Ready Deliverables by:
  • Identifying risks
  • Implementing mitigation plans to meet country deliverable timelines and commitments
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
• Contribute to the development of local Standard Operating Procedures (SOPs)
• Review, negotiate, escalate, and facilitate business approvals for Site Access Forms, Electronic Medical Record (EMR) Access Forms, and institution policies as applicable
• Coordinate with Payment Coordinators / Clinical Trial Coordinator - Finance (CTC-Fs) to address contingency approvals, troubleshoot issues, and amend agreements as required
• Contribute to initiatives and projects that add value to the business, as appropriate/required
• Serve as a process Subject Matter Expert (SME), sharing best practices, recommending continuous improvements, and providing training as required
• Act as a buddy/mentor and share best practices with the COM team as appropriate/required
• Indirectly influence investigators, external partners, and country operations to successfully deliver clinical and financial contracts within fair market value
• Partner internally with Global Clinical Trial Operations (GCTO) country operations, finance, regulatory affairs, pharmacovigilance, legal, and regional operations, as well as Headquarters (HQ) functional areas; collaborate externally with vendors and sites

Core Competencies

• Expertise of core clinical systems, tools, and metrics
• Strong verbal and written influencing and training/mentoring skills, in the local language and English
• Strong coordination and organizational skills
• Knowledge of budget and contract negotiation and how these impact study start-up
• Ability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues, with minimal support from the Sr. COM or manager
• Ability to make decisions independently with limited oversight from the Sr. COM or manager
• Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally
• Ability to lead a team of CTCs, as applicable

Behavioral Expectations

• Problem solving is essential
• Proactively identify issues and risks, analyze root cause, propose solutions, and escalate to management as applicable
• Ability to manage time effectively, prioritize deliverables, and handle conflict and problem-solving
• Strong communication, leadership, and negotiation skills, with influencing and training/mentoring skills in both written and verbal formats (local language and English)
• Ability to focus on multiple deliverables and protocols simultaneously
• Ability to work effectively in a remote, virtual environment with a wide range of people
• Positive, growth-oriented mindset; ability to work independently and be self-driven
• Ability to directly influence site staff

Education and Experience

• Bachelor’s Degree or higher
• 3+ years of experience negotiating contracts or budgets
• Juris Doctor (JD) degree (preferred)

Required Skills

• Clinical Site Management
• Clinical Trial Compliance
• Clinical Trial Management
• Clinical Trials Operations
• ICH GCP Guidelines
• Influencing Skills
• Leadership
• Negotiation
• Problem Solving
• Project Management
• Quality Control Management
• Regulatory Compliance

Preferred Skills

• Clinical Research

Compensation & Benefits

• Salary range: $117,000.00 - $184,200.00
• Eligibility for annual bonus and long-term incentive, if applicable
• Comprehensive benefits package including medical, dental, vision, other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days

Location / Work Details

• Flexible work arrangements: Remote
• Shift: 1st - Day
• Travel requirements: 10%
• Relocation: No relocation
• VISA sponsorship: No
• Valid driving license: No
• Hazardous materials: N/A

US and Puerto Rico Residents Only

Application accommodations are available during the application or hiring process upon request.

Local Resident Considerations

• San Francisco Residents Only: The organization will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance.
• Los Angeles Residents Only: The organization will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Other Information

• Employee status: Regular
• Job posting end date: 10/19/2026 (effective until 11:59:59 PM on the day BEFORE the listed end date)
• Requisition ID: R421622