Regional Project Lead

Summary

Join PSI, a dynamic global company, as a Regional Project Lead and manage and coordinate project teams across designated countries. You will ensure consistency in Clinical Operations processes, meeting study milestones, and compliance with regulations. Responsibilities include project planning, implementation, and management; acting as a primary contact for the project team; reporting project status; developing project documents; managing KPIs; and ensuring timeline and enrollment targets are met. You will also coordinate site startup, budget negotiations, and team performance. This role requires a life sciences degree or equivalent, extensive clinical research experience, and strong leadership skills. Experience in oncology is preferred.

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 4 years of experience in Clinical Research and site monitoring activities
• At least 2 years of experience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent
• 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

Responsibilities

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

Preferred Qualifications

Experience in Oncology