Mgr-Trial Monitoring
Core
Leads and oversees the clinical trial monitoring program for a diverse portfolio of studies, including complex, multi-site IND and IDE clinical research.
Role type
Senior management clinical trial monitoring manager
Builds
Clinical trial monitoring programs and oversight systems for St. Jude-sponsored research
Domain
Clinical research operations / Regulatory compliance
Required skills
Vendor management, Change management, Transformational leadership, Team supervision, Process improvement, Regulatory compliance (ICH/GCP), Study lifecycle management, Resource allocation, Protocol development, Stakeholder liaison
Preferred skills
Multi-site trial experience, Outsourced monitoring oversight, Data quality system development, Grant development advisory, Cross-functional collaboration
Technologies
CTMS, eTMF
Responsibilities
Supervise and develop monitoring personnel, manage assignments and performance metrics, review monitoring plans and reports, provide oversight of outsourced monitoring activities, develop methods and systems to support data quality, act as liaison between Principal Investigators and external bodies, mentor team members, track resource allocations, engage in hiring and performance management.
Seniority
Manager, hands-on leadership