Regional Project Lead

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Optimize the operations of project teams and maintain uniformity of Clinical Operations processes throughout the Asia Pacific region.

• Ensure that project teams meet study milestones at the country level.

• Communicate study progress to clients and global stakeholders.

• Serve as the project management liaison for the project team and PSI support services.

• Conduct study status reviews and progress reporting; gather and disseminate project status updates.

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

• Ensure that project timelines and subject enrollment goals are achieved.

• Coordinate the upkeep of study-specific and corporate tracking systems.

• Manage site selection and initiation, as well as site contractual and budget negotiations.

• Oversee project team and site training; provide field training for monitors tailored to project requirements.

• Guarantee team adherence to the project-specific training matrix.

• Supervise the preparation, execution, and reporting of site selection, site initiation, routine monitoring, and closeout visits.

• Review site visit reports to ensure compliance with monitoring and reporting standards.

• Oversee payments to investigators and sites.

• Supervise project team preparation for study audits/inspections and address findings from audits/inspections.

• Participate in regional project oversight for APAC as necessary.

⛳️ Requirements

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

• A minimum of 4 years of site monitoring experience.

• At least 2 years of experience as a Lead Monitor, preferably in a regional context.

• Proven experience supervising clinical project activities and leading clinical project teams.

• Preferably experienced in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication.

• Strong communication, presentation, and customer service abilities.

• Effective team building, leadership, and organizational skills.

• Full working proficiency in English.

• Proficient in MS Office applications, including MS Project.

🏝️ Benefits

• A stable and secure workplace.

• Opportunities for professional development and investment in employees’ success.

• An inclusive culture where colleagues feel welcomed and valued.

• Remote work option.