Clinical Research

• Direct CDM team activities to complete project deliverables on schedule, within quality standards, requirements, and budget from study start-up through archival
• Serve as CTI CDM representative on project teams
• Recommend work-process improvements and respond to questions about CDM processes, timelines, and data quality
• Maintain relationships with internal customers and sponsors, providing project updates and coordinated plans
• Establish CDM deliverables, time estimates, data-cleaning guidelines, conventions, GSOPs, workflows, and related processes
• Monitor timelines, enrollment, data collection, quality, GSOP compliance, workflow, and project budgets
• Identify out-of-scope activities and manage sponsor or management approvals and cost documentation
• Provide or arrange project-specific training and mentor lower-level Clinical Data Managers
• Develop accurate project reports for sponsors, project teams, and CTI management
• Coordinate receipt, handling, and reconciliation of external data sources including central laboratory, ECG, and serious adverse events data
• Prepare for and participate in meetings, complete action items, and provide input
• Maintain study documentation and CDM project plans reflecting deviations and scope changes
• Conduct post-mortem analyses and provide study metrics to CDM management

Clinical Research jobs in Kentucky

Senior Clinical Data Manager