Clinical Regional Project Lead
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Job Description
Regional clinical trial lead managing oncology projects for PSI, a contract research organization. Coordinating country teams, monitoring, regulatory submissions, milestones, training, and site operations.
Responsibilities:
- Oversee, manage, and coordinate clinical trial project-team activities in designated countries and ensure consistency of Clinical Operations processes across regions
- Ensure study milestones, timelines, and subject-enrollment targets 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 provide progress reporting
- 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 for designated countries and clinical project-team members
- 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
- Provide field training to 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 project-team preparation for audits/inspections and resolution of findings
- Coordinate supervised monitoring visits
- Review site visit reports and ensure monitoring/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 by the Project Manager
Requirements:
- 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 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
Benefits:
- Remote work option
- Hands-on involvement in every aspect of the study
- Career growth opportunities
- Work with a company that puts its people first
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