Alliance for Clinical Trials in Oncology

Clinical Research

• Identify, assess, document, escalate, and manage study risks and operational issues
• Develop and implement mitigation and corrective action strategies
• Develop and maintain project plans, schedules, projections, resource plans, and status reports
• Lead and coordinate cross-functional team activities for assigned clinical trials
• Support study development and lead operational planning, implementation, conduct, and management from initiation through completion
• Review and support development of study-related materials, including monitoring reports and clinical trial agreements
• Support budget development and related scope of work
• Participate in vendor identification, evaluation, selection, contracting, and performance oversight
• Work with Regulatory, Quality, and other staff to maintain inspection-readiness
• Coordinate study information and records supporting registration objectives
• Track study progress against timelines, milestones, budgets, accrual goals, and operational components
• Participate in SOP and study operations process/system development and implementation
• Manage multiple projects and responsibilities within time constraints
• Serve as project manager for industry collaborations and vendor management
• Liaise with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel
• Serve as primary point of contact for industry partners
• Ensure contract deliverables are fulfilled according to milestones
• Analyze study performance metrics and operational data
• Oversee site performance, enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study activities
• Implement study plans and lead accrual enhancement initiatives
• Participate in and conduct visits/meetings with investigative sites, physicians, vendors, and consultants
• Build relationships with site staff and address study management issues
• Conduct site management while maintaining inspection-readiness
• Oversee monitoring CROs, including performance, reports, deliverables, timelines, quality metrics, escalation, and follow-up
• Develop and contribute to study reports, presentations, and stakeholder status updates
• Contribute to study-level quality management, KPI monitoring, quality concern escalation, CAPA implementation, study documentation, and Quality Monitoring and Management Committee activities

Clinical Study Manager