Regional Project Lead
Core
Drive successful delivery of clinical trials across multiple countries, ensuring efficient execution and high quality standards.
Role type
Senior Clinical Trial Regional Project Lead
Builds
Clinical trials for sponsors in Oncology and/or Gastroenterology
Domain
Clinical Research / Life Sciences
Required skills
Clinical Trial Management, Independent on-site monitoring, Oncology expertise, Gastroenterology expertise, Project planning, KPI management, Regulatory submissions, Site selection and initiation, Audit/inspection management, Therapeutic area training, Contract negotiation, Budget management
Preferred skills
MS Project, Team leadership, Stakeholder management
Technologies
MS Office, MS Project
Responsibilities
Ensure planning, implementation, and management of projects in compliance with ICH-GCP; Act as primary or secondary project management contact; Perform study status review and progress reporting; Develop and update project planning documents and manuals; Manage and report on KPIs for designated countries; Ensure project timelines and subject enrollment targets are met; Coordinate site contractual startup and budget negotiations; Establish communication lines and supervise clinical project team members; Identify, escalate, and resolve resourcing and performance issues; Conduct and supervise therapeutic area training; Prepare presentations and conduct training of Investigators; Supervise preparation, conduct, and reporting of site selection, initiation, routine monitoring, and closeout visits; Oversee investigator and site payments and query resolution; Supervise project team preparation for study audits/inspections; Coordinate conduct of supervised monitoring visits; Review site visit reports; Coordinate Regulatory and Ethics Committee submissions; Oversee safety information flow and participate in feasibility research.
Seniority
Senior, hands-on IC with leadership responsibilities