Clinical Study Manager

Project Management

• Proactively identifies, assesses, documents, escalates, and manages study risks and operational issues; develops and implements mitigation and corrective action strategies, as appropriate
• Develops and maintains detailed project plans, schedules, project projections, resource plans and status reports, as appropriate
• Leads and coordinates cross-functional team activities for assigned clinical trials.
• Supports study development and leads the operational planning, implementation, conduct, and management of assigned studies from initiation through completion.
• Reviews and supports development of study-related materials including, but not limited to monitoring reports, clinical trial agreements, etc. where needed
• Support budget development and related scope of work
• Participates in vendor identification, evaluation, selection, and contracting activities, as applicable, and provides ongoing oversight of vendor performance, deliverables, timelines
• Works with Regulatory, Quality, and other staff members to maintain inspection-readiness for assigned studies
• Coordinates and maintains relevant study information and records in support of registration objectives, as applicable
• Track study progress in reference to projected timelines, established milestones, available budget, accrual goals, and other operational components, as applicable
• Participates in the development and implementation of SOPs and study operations processes and systems
• Willingness and capability to handle multiple projects and responsibilities in consideration of known time constraints
• Serve as the project manager for Industry collaborations and vendor management, managing multiple aspects of study development and working closely with the program manager, executive officer and other study team members
• Represents Industry collaborations on the cross-functional project team and liaises with medical, regulatory, quality, protocol, legal, statistical, data management, and financial personnel
• Serve as primary point-of-contact for industry partners
• Ensure deliverables are fulfilled according to milestones within the contract

Clinical Study Management

• Analyzes study performance metrics and operational data to identify trends, risks, and opportunities for corrective action
• Provides oversight and management of site performance, including enrollment/accrual, study conduct, protocol compliance, operational issues, and timely completion of study-related activities
• Works closely with the study teams to implement specific study plans
• Collaborates with study teams to lead accrual enhancement initiatives, as needed
• Implements and monitors processes that support ongoing inspection-readiness
• Participates in and conducts visits/meetings with investigative sites, physicians, vendors and consultants as needed
• Helps build and maintain relationships with site staff in support of the study and address study management issues
• Conducts site management while following appropriate procedures to maintain inspection-readiness status
• Provides oversight of monitoring CROs including monitoring performance, reports, deliverables, timelines, quality metrics, issue escalation, and follow-up
• Develops and/or contributes to study-related reports, presentations, and status updates for internal and external stakeholders
• Contributes to study-level quality management by monitoring key performance indicators, identifying and escalating quality concerns, supporting corrective and preventative action plan implementation, maintaining appropriate study documentations, and participating in the Quality Monitoring and Management Committee