Lead Site Contract Manager - Clinical Trials

About the role

Johnson & Johnson is hiring a Lead Site Contract Manager in its R&D Operations, Site Engagement Group, Contract & Grants, Global Development unit, based in Chiyoda, Tokyo. The role covers the development and analysis of site contracts for clinical trials, including drafting, negotiating and finalizing agreements, and overseeing a Clinical Research Organization (CRO) responsible for contract negotiations. It also supports the clinical team in pricing, planning, execution and control of contracts.

Key responsibilities

• Prepare, negotiate and finalize clinical trial agreements and ancillary agreements for company-sponsored and investigator-initiated studies, either directly with sites or through a CRO.
• Analyze requirements and translate them into contracts and budgets, and review study-specific tracking requirements for accuracy and completeness.
• Review contractual terms with global teams, assess legal and budget risks, and partner with Compliance, Risk Management, Privacy and other stakeholders.
• Analyze investigator fees against fair market value and J&J pricing guidelines, and lead approval escalations as needed.
• Support negotiations on confidentiality agreements, informed consent forms and other ancillary documents, and manage the contract amendment lifecycle.
• Provide project management oversight to CROs, including training and supervision, and onboard and train new staff while mentoring teams.
• Assist in resolving site and study concerns, liaise with management on staff performance and development, and implement process improvements.
• Potentially assist in reviewing and managing payments, and help ensure investigator grants comply with study cost and compliance guidelines.

Required profile

• Bachelor's degree in a scientific or business discipline.
• 3 to 5 years of experience in the pharmaceutical industry or clinical research, or equivalent competencies.
• 2 years of negotiation and contract experience, with a working knowledge of the clinical development process.
• Fluency in English; travel of about 10%.
• Previous experience in virtual teams preferred.

Required skills

• Comprehensive knowledge of clinical research processes and clinical trial regulations.
• Working knowledge of healthcare compliance guidance such as HIPAA, FCPA and Safe Harbor.
• Working knowledge of MS Office and database management.
• Negotiation, problem-solving and communication skills.