Clinical Regional Project Lead

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

📋 Description

• Optimize the operations of project teams and ensure uniformity in 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 the project team and PSI support services.

• Conduct reviews of study status and report on progress.

• Gather and communicate updates on project status.

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

• Ensure adherence to project timelines and target subject enrollment goals.

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

• Oversee the selection and initiation of sites, as well as contractual and budget negotiations.

• Direct the training of project teams and sites, including field training for monitors.

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

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

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

• Manage payments to investigators and sites.

• Oversee the project team's readiness for study audits/inspections and the resolution of any audit/inspection findings.

• Participate in regional project oversight for APAC as required.

⛳️ Requirements

• MPharm, RN, or a university/college degree in Life Sciences, or an equivalent mix 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 role.

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

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

• Strong communication, presentation, and customer service skills.

• Proficient in 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 a commitment to employee success.

• An inclusive culture where colleagues feel welcomed and valued.

• Option for remote work.