PSI CRO is hiring a Regional Project Lead to manage and coordinate project teams in designated countries, ensuring clinical operations processes are consistent across regions. You will advance your career by leading challenging full-service projects on a country and regional level, gaining hands-on involvement in all aspects of studies within a company that puts its people first.
What You'll Do
- Ensure planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled 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
- 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
- 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, CRF data retrieval/upload and monitoring, 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/approve project related expenses and timesheets
What We're Looking For
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Significant experience in Clinical Research and site monitoring
- 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
Nice to Have
- Experience in Oncology is preferred.
Technical Stack
- MS Office
- MS Project
PSI CRO is an equal opportunity employer.
