Regional Project Lead

PSI CRO

6d

About The Position

The Regional Project Lead streamlines project-team activities and ensures consistent Clinical Operations processes across the Asia Pacific region. The role supports project teams in meeting study milestones at the country level and reports study progress to clients and global stakeholders. Responsibilities may also include regional project oversight for APAC.

Requirements

• MPharm, RN, or a university/college degree in Life Sciences, or an equivalent combination of education, training, and experience.
• At least 4 years of site-monitoring experience.
• At least 2 years of experience as a Lead Monitor, preferably in a regional capacity.
• Experience supervising clinical project activities and leading clinical project teams.
• 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.

Nice To Haves

• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or a rare-disease indication is preferable.
• Lead Monitor experience in a regional capacity is preferred.

Responsibilities

• Act as the project management contact for the project team and PSI support services.
• Review study status and report progress, including collecting and reporting project status updates.
• Develop and update project planning documents, essential study documents, and project manuals or instructions.
• Ensure project timelines and subject-enrollment targets are met.
• Coordinate maintenance of study-specific and corporate tracking systems.
• Oversee site selection and startup, including site contractual and budget negotiations.
• Supervise project-team and site training, and provide project-specific field training to monitors.
• Ensure the project team complies with the 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 audit and inspection findings.
• Potentially provide regional project oversight for APAC.

Benefits

• The company invests in employees’ professional development and success.
• The company describes itself as a stable and secure workplace, with minimal staff turnover.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level