Clinical Trial Manager II

About the role

Syneos Health is hiring a Clinical Trial Manager II in Athens, Greece, 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 covers site interactions from post-activation through closeout, and may involve larger, more complex trials.

Key responsibilities

• Manage site interactions after activation until closeout, including patient recruitment and investigator payments.
• Identify risks to protocol execution and propose and implement risk mitigations; escalate timeline, quality and budget risks to the project manager.
• Take part in key meetings such as the Kick Off Meeting and act as an escalation point for investigators and site staff.
• Coordinate with Study Start Up, Patient Recruitment and Data Management to meet site activation, enrollment and database lock targets.
• Maintain clinical study tools and templates, including the Clinical Monitoring Plan, and set up CTMS, dashboards and systems, including UAT.
• Train the study team on protocol specifics, CRFs, dashboards, sponsor SOPs and timelines.
• 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 in CTMS.
• Support inspection readiness and provide status updates and solutions to the client and project management.
• Assess compliance with the monitoring strategy and corrective actions, and support data cut-off and lock deadlines.

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience.
• Demonstrated ability to lead 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.
• Good communication, presentation and interpersonal skills, strong conflict resolution and problem-solving abilities.
• Modest travel, around 20%, may be required.

Required skills

• Knowledge of Good Clinical Practice (ICH GCP) and other applicable regulatory requirements.
• Good computer skills.
• Experience with CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards.