Clinical Trial Manager II
syneoshealth · GRC-Athens-Hybrid
Job description
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 and regulatory compliance and data integrity. It covers site interactions from post-activation through closeout.
Key responsibilities
- Manage site interactions after activation until closeout, including patient recruitment and investigator payments
- Identify risks to protocol execution and propose 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 UAT
- Train the study team on protocol, CRFs, dashboards, SOPs and timelines
- Oversee CRAs and Central Monitors, resourcing, site assignments and compliance with the monitoring strategy and risk plans
- Review monitoring documentation (calls, visit reports, correspondence) and document revisions in CTMS
- Support inspection readiness and provide status updates and solutions to the client and leadership
Required profile
- Bachelor's degree or RN in a related field, or equivalent education, training and experience
- Demonstrated ability to lead teams and 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 budgets and financial principles
- Good communication, presentation, conflict resolution and problem-solving skills
- Modest travel, around 20%
Required skills
- Knowledge of Good Clinical Practice (ICH GCP) and other regulatory requirements
- Computer skills
- Familiarity with CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards
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Published 50 minutes ago
Expires 1 month from now
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syneoshealth
GRC-Athens-Hybrid
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