Clinical Regional Project Lead

• Oversee, manage, and coordinate activities of project teams in designated countries
• Ensure consistency of Clinical Operations processes across regions
• Ensure study milestones are met at country and regional levels
• Plan, implement, and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents
• Act as primary or secondary project management contact for project teams and PSI support services in designated countries
• Review study status and report progress
• Collect and report project status updates internally and externally
• Develop and update project planning documents, essential study documents, and project manuals/instructions
• Manage and report Key Performance Indicators (KPIs)
• Ensure project timelines and subject enrollment targets are met
• Coordinate maintenance of study-specific and corporate tracking systems
• Coordinate site contractual startup and budget negotiations
• Establish communication lines and supervise clinical project team members’ performance
• Identify, escalate, and resolve resourcing and performance issues
• Conduct and supervise therapeutic area training
• Prepare presentations and conduct Investigator training
• Ensure compliance with the project-specific training matrix
• Perform field training of Monitors
• Supervise site selection, site initiation, routine monitoring, and closeout visits
• Oversee investigator and site payments, CRF data retrieval/upload and monitoring, and query resolution
• Supervise project team preparation for study audits/inspections and resolution of findings
• Coordinate supervised monitoring visits
• Review site visit reports and ensure monitoring and reporting standards are met
• Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications
• Oversee safety information flow and participate in feasibility research
• Review/approve project-related expenses and timesheets when delegated

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
• Prior experience in Clinical Research and on-site monitoring is required
• Prior experience monitoring within the US
• Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required
• Experience in Oncology is required
• Experience in GI is preferred
• Full working proficiency in English
• Proficiency in MS Office applications, including MS Project
• Communication, presentation and customer-service skills
• Ability to negotiate and build relationships at all levels
• Team building, leadership and organizational skills

• Remote work options
• Career advancement opportunities
• Opportunity to learn new things
• Employee-focused company culture