Clinical Regional Project Lead
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Job Description
Clinical Regional Project Lead coordinating APAC clinical trials for PSI, a global contract research organization. Managing project teams, milestones, site operations, training, payments, and audit readiness.
Responsibilities:
- Streamline activities of project teams and ensure consistency of Clinical Operations processes across the Asia Pacific region
- Ensure study milestones are met by project teams 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, project manuals and instructions
- Ensure project timelines and subject enrollment targets are met
- Coordinate maintenance of study-specific and corporate tracking systems
- Oversee site selection and startup, site contractual and budget negotiations
- Supervise project team and site training, including field training of monitors
- 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 and 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 preferred
- 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 investment in career success
- Stable and secure workplace
- Inclusive culture and welcoming environment
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