Regional Project Lead
Core
Streamline clinical project team activities and ensure consistency of Clinical Operations processes across North America, meeting study milestones and reporting progress to clients and global stakeholders.
Role type
Senior Clinical Project Lead (Regional)
Builds
Clinical trial studies for pharmaceutical clients across North America
Domain
Life Sciences / Clinical Research / Contract Research Organization (CRO)
Deliverable
client delivery
Required skills
Project management, study status review and reporting, project planning, site selection and startup, budget negotiations, team supervision and training, audit/inspection preparation and resolution, investigator payment oversight
Preferred skills
Oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indication experience
Technologies
MS Office, MS Project
Responsibilities
Act as project management contact for project teams and PSI support services; Develop and update project planning documents, essential study documents, and project manuals; Coordinate maintenance of study-specific and corporate tracking systems; Oversee site selection, startup, contractual and budget negotiations; Supervise project team and site training; Supervise preparation, conduct, and reporting of site selection, initiation, routine monitoring, and closeout visits; Review site visit reports to ensure monitoring and reporting standards are met; Oversee investigator and site payments; Supervise project team preparation for study audits/inspections and resolution of findings
Seniority
Senior, hands-on IC with leadership responsibilities
