Clinical Research

• Provide site management oversight, clinical monitoring and central monitoring deliverables, focusing on patient safety, protocol/GCP/regulatory compliance and data integrity
• Oversee site interactions from activation through closeout, including patient recruitment and investigator payments
• Identify critical data, process and protocol-execution risks and develop risk mitigations
• Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations and parameters
• Identify and escalate risks affecting timelines, quality, budget or contracted scope
• Participate in and present at key meetings, including Kick Off Meetings
• Serve as an escalation point for investigator site staff and interact with principal investigators and other site staff by phone or in person
• Collaborate with Study Start Up, Patient Recruitment, Data Management and other functional leaders to meet study milestones
• Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan
• Ensure CTMS, dashboards and other systems are configured and available, including overseeing UAT and access/audit trail reviews
• Coordinate training for study teams on protocols, CRF completion, dashboards, SOPs, plans and timelines
• Oversee CRA and Central Monitor resourcing, site assignments and team conduct
• Ensure quality and visibility of clinical monitoring, central monitoring and site management deliverables using approved systems and tracking tools
• Review project oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePRO, TMF, IVRS/IWRS and central monitoring dashboards
• Participate in development of study risk assessment plans and ensure assigned team members comply with monitoring strategies and risk plans
• Review the quality and content of monitoring documentation and ensure timely delivery according to company and sponsor specifications
• Interact with clients, project management, leadership and functional departments; provide status updates and solutions for protocol-execution and site-management obstacles
• Support inspection readiness for clinical trial management scope
• Oversee CRAs and Central Monitors, assess process/training/CMP compliance, identify emerging risks and support corrective action plans
• Support activities to achieve data cut and lock deadlines
• Provide performance feedback to line managers on staff strengths and development areas
• May be assigned to larger, more complex trials

Explore Clinical Trial Manager II at Syneos Health. Review requirements and application details.

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