Regional Project Lead
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Job Description
Regional Project Lead overseeing clinical trial delivery across countries for PSI CRO, a global contract research organization. Supervising teams, monitoring performance, and ensuring regulatory and quality compliance.
Responsibilities:
- Plan, implement, and manage clinical research 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 for designated regions internally and externally
- Develop and update project planning documents, essential study documents, project manuals, and instructions
- Manage and report KPIs for designated countries and clinical project team members
- Ensure project timelines and subject enrollment targets are met in designated countries
- Coordinate study-specific and corporate tracking systems
- Coordinate site contractual startup and budget negotiations
- Establish project-team communication lines and supervise clinical project team performance
- Identify, escalate, and resolve resourcing and performance issues
- Conduct or supervise therapeutic-area training and Investigator training
- Ensure compliance with project-specific training matrices
- Conduct field training of Monitors
- Supervise site selection, site initiation, routine monitoring, and closeout visits
- Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution
- Supervise preparation for study audits/inspections and resolution of findings
- Coordinate supervised monitoring visits and review site visit reports
- Coordinate Regulatory and Ethics Committee submissions and notifications
- Oversee safety information flow and participate in feasibility research
- Review/approve project expenses and timesheets when delegated
Requirements:
- College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
- Prior experience in Clinical Research and independent on-site monitoring is required
- Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent is required
- Therapeutic expertise in Oncology and/or Gastroenterology required
- 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
- Must not require a work visa for employment or continued employment now or anytime in the future
Benefits:
- Flexible working arrangements
- Career growth and professional development
- Opportunities to lead complex global studies
- Collaborative, people-first culture
- Stable organization supporting long-term careers
- Meaningful work advancing innovative therapies to patients
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