Senior Clinical Trial Manager II - FSP BU, South Korea

About the role

Syneos Health is hiring a Senior Clinical Trial Manager II for its Functional Service Provider business unit covering South Korea. The role oversees site management, clinical monitoring and central monitoring, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. It works remotely.

Key responsibilities

• Oversee site interactions from post-activation through site 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 investigator site staff
• 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 project oversight dashboards (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, Central Monitoring dashboards) and site and central monitoring documentation
• Support inspection readiness and provide status updates and solutions to the client and project management
• Assess staff performance and give feedback to line managers; may be assigned to larger, more complex trials

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 to project milestones and to work in an international environment
• Expertise in site management and monitoring (clinical or central); preferred experience with risk-based monitoring
• Understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements

Required skills

• Good computer skills
• Good communication, presentation and interpersonal skills, and strong conflict resolution skills