Centralized Monitoring Lead- Sponsor Dedicated
Core
Partners with Clinical Leads and Site Monitors to execute clinical trials, managing study start-up, ongoing monitoring, and closeout while leading a team of Central Monitors and Clinical Analyst Support.
Role type
Senior Centralized Monitoring Lead (Clinical Operations)
Builds
Clinical trial execution and site management for life sciences clients
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial conduct, ICH GCP compliance, risk assessment, data trending, team leadership, stakeholder management, resource management, action item tracking, investigator payment review
Preferred skills
Mentoring, cross-cultural collaboration, problem solving
Technologies
QRPM, iSite Pack, DTE Alert/Triggers dashboard, RM Dashboard, MS Office
Responsibilities
Maintain Clinical Operations Plan and develop study templates; manage study start-up and site activation; coordinate study initiation and monitoring resources; perform ongoing risk assessment and data trending; manage DTE alerts and action items; review site visit reports and TMF documents; manage team resourcing and training; approve investigator payments.
Seniority
Senior, hands-on IC with mentorship
