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
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