Project Manager

• Provide project management oversight, clinical monitoring, and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance, and data integrity
• Oversee site interactions post activation through site closeout, including patient recruitment and investigator payments
• Identify critical data/process and protocol execution risks and propose/implement mitigations (RACT)
• Review study scope of work, budget and protocol content and ensure clinical team awareness of contractual obligations
• Use operational data and metrics to identify risks to timelines, quality and budget and escalate as needed
• Participate and present in key meetings (eg. Kick Off Meeting) and serve as escalation point for site communications
• Collaborate with Study Start Up, Patient Recruitment and Data Management to coordinate handoffs and meet study milestones
• Develop and maintain clinical study tools and templates, and ensure CTMS/dashboards/systems setup and UAT
• Coordinate training for study team on protocol specifics, CRF completion, dashboards, SOPs and data plans
• Oversee resourcing allocations for CRAs/Central Monitors and ensure quality of monitoring and site management deliverables
• Review monitoring documentation and ensure deliverables meet company/sponsor specifications and timelines
• Provide status updates to clients, project management and leadership and support inspection readiness
• Contribute to financial/metric reporting and assist with budget/contingency planning and invoice reviews

Project Manager

Senior Project Manager, Korean Speaking