Regional Project Lead
Core
Streamline clinical project team activities and ensure consistency of Clinical Operations processes across regions to meet study milestones.
Role type
Senior Clinical Project Lead (Regional)
Builds
Clinical trial studies for pharmaceutical clients
Domain
Life Sciences / Clinical Research / CRO
Required skills
Project management, Site monitoring, Team leadership, Study planning, Site selection and startup, Budget negotiation, Training delivery, Audit/inspection management, Compliance oversight, Data reporting
Preferred skills
Oncology, Gastroenterology, Infectious diseases, Autoimmune diseases, Rare disease indications, Regional project oversight (APAC)
Technologies
MS Office, MS Project
Responsibilities
Act as project management contact for project teams and PSI support services; Perform study status reviews and progress reporting; Develop and update project planning documents and study manuals; Ensure project timelines and subject enrollment targets are met; Coordinate maintenance of study-specific and corporate tracking systems; Oversee site selection, startup, and contractual/budget negotiations; Supervise project team and site training; Supervise preparation, conduct, and reporting of site visits; Review site visit reports to ensure monitoring standards; Oversee investigator and site payments; Supervise preparation for study audits/inspections.
Seniority
Senior, hands-on IC with leadership responsibilities