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Clinical Trial Manager II

syneoshealth · GRC-Athens-Hybrid

Νέο
Hybrid Mid 🇬🇧 English
Clinical Monitoring Site Management Risk-Based Monitoring ICH GCP CTMS EDC ePROs TMF

Περιγραφή θέσης

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

Questions fréquentes

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Source : ats:workday

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GRC-Athens-Hybrid