Clinical Operations

• Serve as the primary point of contact for industry-sponsored clinical trials and assigned projects
• Collaborate with department heads to ensure project service quality, resolve issues proactively, and improve project management systems and ARO efficiency
• Mentor Clinical Operations Managers
• Oversee clinical operations management activities delegated to Clinical Trial Managers
• Manage site identification, evaluation, initiation, contracting, budget negotiation, monitoring, regulatory documentation, IRB submissions, site materials, monitoring reports, site compliance, enrollment reports, and site payments
• Contribute to SOP review and development and process improvement
• Define and monitor project scope, timelines, and deliverables from initiation through closeout
• Identify project-specific training and ensure completion and documentation
• Oversee trial-related activities and provide performance feedback
• Participate in study database review, development, and testing
• Track and manage investigational product or device disposition
• Develop and manage site and vendor contracts and vendor services
• Advise on and review project essential documents, including protocols, project management plans, case report forms, statistical analysis plans, ICF templates, study manuals, monitoring plans, and reports
• Develop and manage multidisciplinary project teams and organize project team meetings
• Identify project issues, propose resolutions, and track implementation through completion and efficacy checks
• Ensure quality of project services and deliverables
• Provide sponsor updates and reports
• Plan and oversee investigator meetings
• Support business development with budgets, proposals, change orders, benchmarking, and service agreements
• Communicate project scope changes and project status to CPC management and sponsors
• Provide TMF scope information and maintain compliance with regulations, CPC policies, SOPs, and work instructions
• Supervise and evaluate direct-report staff, if applicable
• Manage Endpoint and Specialty Services scope, timelines, and deliverables
• Manage contracted deliverables for external committees, including scheduling, minutes, and meeting materials
• Oversee SAE processes and safety plans
• Track, process, and quality-check photos, acetate tracings, and other endpoint source documents
• Oversee data entry and cleaning for study databases and maintain data management documentation
• Manage endpoint materials supplied to study sites
• Provide site feedback on tracing and quality issues
• Manage and conduct CPC Core Lab activities as necessary

Explore Senior Clinical Trial Operations Manager at CPC. Review requirements and application details.