APAC Regional Clinical Operations Lead

Psi CRO; Kuala Lumpur; On-site; MYR 120,000 - 200,000; Full time

Job summary

PSI CRO is seeking a capable lead monitor to streamline Clinical Operations across the Asia Pacific region. You will ensure study milestones are met, report progress to clients and global stakeholders, and act as the PM contact for PSI support services.

Ideal candidates have 4+ years of site monitoring experience, leadership ability, and English proficiency. Oncology and other therapeutic areas are preferable; MS Office and MS Project skills are required.

Qualifications

• MPharm, RN or Life Sciences degree or equivalent combination of education/training/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.
• Full working proficiency in English.
• Proficiency in MS Office applications, including MS Project.

Responsibilities

• 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.

Skills

Communication skills

English proficiency

Leadership

Team building

Education

MPharm, RN or Life Sciences degree

Tools

MS Office

MS Project

Job description

PSI CRO is seeking a capable lead monitor to streamline Clinical Operations across the Asia Pacific region. You will ensure study milestones are met, report progress to clients and global stakeholders, and act as the PM contact for PSI support services.

Ideal candidates have 4+ years of site monitoring experience, leadership ability, and English proficiency. Oncology and other therapeutic areas are preferable; MS Office and MS Project skills are required.