PSI CRO is seeking a Regional Project Lead to manage and coordinate the activities of project teams within designated countries, ensuring consistency in Clinical Operations processes across regions. In this role, you will be critical in ensuring study milestones are met on both a country and regional level. You will join a global company of more than 2,800 dedicated professionals who work on the front-line of medical science to bring new medicines to those who need them.
What You'll Do
- Ensure planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, and essential study documents.
- Act as a primary or secondary project management contact for the project team and PSI support services in designated countries.
- Perform study status review and progress reporting when delegated.
- 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 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.
- Prepare presentations and conduct training for investigators.
- Ensure team compliance with the project-specific training matrix.
- Perform field training for Monitors tailored to the project needs.
- Supervise preparation, conduct, and reporting of site selection, initiation, routine monitoring, and closeout visits.
- Oversee investigator and site payments, CRF data retrieval/upload, and the query resolution process.
- Supervise project team preparation for study audits/inspections and resolution of 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 and approve project-related expenses and timesheets if delegated.
What We're Looking For
- A college/university degree in Life Sciences or an equivalent combination of education, training, and experience.
- A minimum of 5 years of prior experience in Clinical Research, including on-site monitoring.
- Experience as a Study Manager or Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent.
- Required experience in Oncology.
- Full working proficiency in English.
- Proficiency in MS Office applications, including MS Project.
- Strong communication, presentation, and customer-service skills.
- Ability to negotiate and build relationships at all levels.
- Team building, leadership, and organizational skills.
Nice to Have
- Experience in GI is preferred.
Technical Stack
- MS Office applications
- MS Project
PSI CRO is an equal opportunity employer.
