Clinical Trial Manager (FSO)

About the role

Syneos Health is hiring a Clinical Trial Manager (Functional Service Provider, FSO) in Tokyo, working in a hybrid setting. The role oversees site management, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. It involves managing the relationship with investigator sites from post-activation through closeout.

Key responsibilities

• Oversee site interactions from activation to closeout, including patient recruitment and investigator payments
• Identify risks to clinical trial management deliverables (timeline, quality, budget) and escalate them to the project manager; propose and implement risk mitigations
• Take part in key meetings such as the Kick Off Meeting and act as an escalation point for communications with site staff and principal investigators
• Collaborate with Study Start Up, Patient Recruitment and Data Management to meet milestones such as site activation, enrollment and database lock targets
• Maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and other systems, including UAT
• Coordinate training of the study team on protocol, CRFs, dashboards, SOPs and data plans
• Oversee resourcing of CRAs and Central Monitors, site assignments and study team conduct
• Review monitoring documentation (site visit reports, central monitoring reports, site letters) and document revisions and approvals in CTMS
• Provide status updates and solutions to the client and leadership, and support inspection readiness
• Support data cut and lock deadlines and provide feedback to line managers on staff performance

Required profile

• Bachelor's degree or RN in a related field, or equivalent combination of education, training and experience
• Demonstrated ability to lead and align teams toward project milestones
• Ability to work in an international environment
• Preferred: experience with risk-based monitoring
• Understanding of clinical trial management financial principles and budget management
• Good computer skills, communication and presentation skills, and strong conflict resolution skills
• Modest travel, approximately 20%

Required skills

• Site management and monitoring (clinical or central)
• Knowledge of Good Clinical Practice (ICH GCP) and other applicable regulatory requirements
• Risk management approach to identifying and mitigating threats to a clinical research project