In this role you will streamline activities of project teams and ensure consistency of Clinical Operations processes across Asia Pacific region. You will ensure meeting study milestones by project teams on a country level, report study progress to clients and global stakeholders.

The scope of responsibilities will include:

• Act as project management contact for the project team and PSI support services.

• Perform study status review and progress reporting, collect and report project status updates.

• Develop and update project planning documents, essential study documents and project manuals/ instructions.

• Ensure that the 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, perform field training of monitors tailored to the 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 ensures monitoring and reporting standards are met.

• Oversee investigator and site payments.

• Supervise project team preparation for study audits/ inspections and resolution of audit/ inspection findings.

• Might be involved in regional project oversight for APAC.

• MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience.

• Minimum 4 years' site monitoring experience and at least 2 years' experience as Lead Monitor, preferably in regional capacity.

• Experience supervising clinical project activities and leading clinical project teams.

• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable.

• Communication, presentation, and customer-service skills.

• Team building, leadership and organizational skills.

• Full working proficiency in English and Thai.

• Proficiency in MS Office applications, including MS Project.

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