Regional Project Lead - Clinical Operations

About the role

PSI, a Contract Research Organization with over 30 years of experience in the pharmaceutical industry, is hiring a Regional Project Lead in Singapore. The role streamlines project team activities and ensures consistency of Clinical Operations processes across regions, while helping project teams meet study milestones on a country level and reporting study progress to clients and global stakeholders.

Key responsibilities

• Act as project management contact for the project team and PSI support services.
• Perform study status reviews, 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, site contractual and budget negotiations.
• Supervise project team and site training, and perform field training of monitors tailored to project needs.
• Ensure team compliance with the project-specific training matrix.
• Supervise preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits, and review site visit reports.
• Oversee investigator and site payments.
• Supervise preparation for study audits and inspections and resolution of findings.
• Might be involved in regional project oversight for APAC.

Required profile

• 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 as Lead Monitor, preferably in a regional capacity.
• Experience supervising clinical project activities and leading clinical project teams.
• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases or other rare disease indications is preferable.
• Full working proficiency in English.

Required skills

• Communication, presentation and customer-service skills.
• Team building, leadership and organizational skills.
• Proficiency in MS Office applications, including MS Project.