Regional Project Lead coordinating North American clinical trials for PSI, a global contract research organization. Overseeing project teams, study milestones, sites, training, payments, and audits.
About the role
- Regional Project Lead coordinating APAC clinical trial operations for PSI, a global contract research organization. Managing milestones, sites, teams, training, budgets, payments, and audit readiness.
Responsibilities
- Streamline activities of project teams and ensure consistency of Clinical Operations processes across the Asia Pacific region
- Ensure project teams meet study milestones at country level
- Report study progress to clients and global stakeholders
- Act as project management contact for project teams and PSI support services
- Review study status and report progress; collect and report project status updates
- Develop and update project planning documents, essential study documents, and project manuals/instructions
- Ensure project timelines and subject enrollment targets are met
- Coordinate maintenance of study-specific and corporate tracking systems
- Oversee site selection and startup, contractual negotiations, and budget negotiations
- Supervise project team and site training; perform field training of monitors tailored to project needs
- Ensure team compliance with project-specific training matrix
- Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits
- Review site visit reports and ensure monitoring and reporting standards are met
- Oversee investigator and site payments
- Supervise project team preparation for study audits/inspections and resolution of findings
- Participate in regional project oversight for APAC as needed
Requirements
- MPharm, RN, or university/college degree in Life Sciences, or equivalent combination of education, training, and experience
- Minimum 4 years of site monitoring experience
- At least 2 years of experience as a Lead Monitor
- Experience supervising clinical project activities and leading clinical project teams
- Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications preferable
- Communication, presentation, and customer-service skills
- Team-building, leadership, and organizational skills
- Full working proficiency in English
- Proficiency in MS Office applications, including MS Project
Benefits
- Remote work
- Professional development and success investment
- Stable and secure workplace
- Inclusive culture
- Diverse and welcoming work environment
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