Clinical Regional Project Lead

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

📋 Description

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

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

• Provide updates on study progress to clients and global stakeholders.

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

• Conduct reviews of study status and progress reporting, gathering and disseminating project status updates.

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

• Ensure adherence to project timelines and subject enrollment objectives.

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

• Manage site selection and startup processes, including contractual and budget negotiations.

• Oversee training for the project team and sites, and provide tailored field training for monitors based on project needs.

• Ensure compliance of the team with the project-specific training matrix.

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

• Review site visit reports to ensure monitoring and reporting standards are upheld.

• Oversee payments to investigators and sites.

• Manage project team preparations for study audits/inspections and address any findings from these audits/inspections.

• May participate in regional project oversight for the APAC region.

⛳️ 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 and a minimum of 2 years as a Lead Monitor, ideally in a regional context.

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

• Background in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferred.

• Strong communication, presentation, and customer service skills.

• Proficient in team building, leadership, and organizational skills.

• Full working proficiency in English.

• Competence in MS Office applications, including MS Project.

🏝️ Benefits

• Opportunities for professional development.