Clinical Regional Project Lead
Core
Senior clinical trial manager overseeing and coordinating project teams across designated countries to ensure consistency of Clinical Operations processes and meet study milestones.
Role type
Senior IC clinical regional project lead
Builds
Clinical trials for oncology and GI therapeutic areas
Domain
Clinical research / Life Sciences
Deliverable
client delivery
Required skills
Clinical trial management, on-site monitoring, study planning, KPI management, site selection and initiation, regulatory and ethics committee submissions, safety information flow, audit/inspection preparation, therapeutic area training, contract negotiation, budget management
Preferred skills
Oncology experience, GI experience
Technologies
MS Office, MS Project
Responsibilities
Ensure planning, implementation, and management of projects in compliance with industry regulations; act as primary or secondary project management contact; perform study status review and progress reporting; collect and report project status updates; develop and update project planning documents and manuals; manage and report on KPIs; ensure project timelines and subject enrollment targets are met; coordinate maintenance of tracking systems; coordinate site contractual startup and budget negotiations; establish communication lines and supervise team performance; identify, escalate, and resolve resourcing and performance issues; conduct and supervise therapeutic area training; prepare presentations and conduct training of Investigators; ensure team compliance with training matrix; perform field training of Monitors; supervise preparation, conduct, and reporting of site visits; oversee investigator and site payments and data retrieval/query resolution; supervise project team preparation for audits/inspections; coordinate conduct of supervised monitoring visits; review site visit reports; coordinate preparation of Regulatory and Ethics Committee submissions; oversee safety information flow and participate in feasibility research; review/approve project expenses and timesheets.
Seniority
Senior, hands-on IC with supervisory responsibilities