Clinical Trial Manager
Core
Manage the day-to-day clinical operations and quality of assigned clinical trials, ensuring ICH GCP compliance and on-time delivery of monitoring activities.
Role type
Clinical Trial Manager (IC)
Builds
Clinical trial studies for sponsors/clients
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial management, ICH GCP guidelines, risk identification and mitigation, study enrollment planning, clinical monitoring plan development, trial master file management, stakeholder management, regulatory compliance, data milestone tracking, vendor management
Preferred skills
Electronic data capture (EDC) systems, electronic clinical trial management (CTMS) systems, vaccination studies, device studies
Technologies
MS Office Suite, EDC systems, CTMS systems
Responsibilities
Manage quality and clinical operations of assigned studies while remaining ICH GCP compliant; Prepare and present investigator meetings; Generate the Clinical Monitoring Plan; Establish and maintain tracking tools for assigned trials; Review monitoring visit reports; Identify and resolve issues related to site management; Develop and track timelines, budget, and performance metrics; Manage study investigators, sites, monitors, and vendors; Conduct co-monitoring visits
Seniority
Mid-level, hands-on IC
