Clinical Trial Cost & Contract Specialist / Lead
Location: Japan
Employment Type: Full-time
Department: Study Start-Up / Contracts & Budgets
Job Summary
We are seeking a Clinical Trial Cost & Contract Specialist to lead the preparation, negotiation, and execution of clinical trial contracts and budget-related documents with medical institutions and other study sites.
Candidates with leadership experience may be appointed as Cost Contract Officer (Lead). In this role, you will oversee contract progress from preparation to initial execution, manage risks, respond to internal stakeholder inquiries, and collaborate closely with cross-functional teams to ensure smooth project delivery.
Our organization aims to be a pioneer among CROs in Fair Market Value (FMV) implementation and improvements that shorten cycle times. You will have opportunities to contribute to process‑improvement initiatives and task forces.
Key Responsibilities
Contract & Budget Negotiation
Prepare and negotiate clinical trial contracts and cost-related documents with medical institutions and external facilities
Ensure compliance with internal policies, FMV guidelines, and relevant regulations
Lead Responsibilities (for Senior Candidates)
Manage contract progress and risk mitigation from initial preparation to first contract execution
Provide guidance and respond to internal stakeholders (Project Managers, CRAs, Legal, Finance, etc.)
Coordinate with cross-functional teams to ensure timely project start-up
Support training and mentoring of junior staff
Process Improvement
Contribute to task forces focused on FMV implementation and operational efficiency
Identify cycle-time bottlenecks and propose improvements
Strengthen best practices and internal standards for contract and budget processes
Required Qualifications
3+ years of experience in the SSU (Study Start-Up) phase of clinical trials, including contract and budget negotiations
Proven leadership experience (team lead, senior specialist, or project lead)
Experience negotiating with external institutions (e.g., hospitals, research sites)
Strong PC skills; ability to create professional documents using Word and Excel
Ability to read and write English at a business level
Preferred Qualifications
Experience managing clinical trial contracts and budgets at:
A medical institution
A clinical trial office
SSU-phase experience as a CRA or Associate CTM
Professional experience using English in daily business interactions
Experience working on global clinical trials