Clinical Regional Project Lead
Core
Senior clinical trial manager overseeing and coordinating project teams across designated countries to ensure study milestones, timelines, and subject enrollment targets are met.
Role type
Senior IC clinical regional project lead
Builds
Clinical trials for oncology and GI therapeutic areas
Domain
Clinical research / Oncology / Gastroenterology
Deliverable
client delivery
Required skills
Clinical trial management, on-site monitoring, study status reporting, KPI management, site selection and initiation oversight, regulatory and ethics committee submission coordination, safety information flow management, audit/inspection preparation, therapeutic area training, contract negotiation, resource management
Preferred skills
GI therapeutic area experience
Technologies
MS Project
Responsibilities
Ensure planning, implementation, and management of projects in compliance with ICH-GCP and industry regulations; Perform study status review and progress reporting; Manage and report on KPIs for designated countries; Coordinate site contractual startup and budget negotiations; Supervise clinical project team members' performance; Conduct and supervise therapeutic area training of the project team; Perform field training of Monitors; Supervise preparation, conduct, and reporting of site selection, initiation, routine monitoring, and closeout visits; Coordinate conduct of supervised monitoring visits; Review site visit reports; Coordinate preparation of Regulatory and Ethics Committee submissions; Oversee safety information flow; Review/approve project related expenses and timesheets.
