Clinical Regional Project Lead

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

📋 Description

• Optimize the operations of project teams to ensure uniformity in 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 primary project management contact for project teams and PSI support services.

• Evaluate study progress and report on status.

• Gather and relay updates on project status.

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

• Ensure adherence to project timelines and subject enrollment goals.

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

• Oversee the processes of site selection and initiation, including site contract and budget negotiations.

• Direct project team and site training, including on-site training for monitors.

• Ensure team compliance 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 compliance with monitoring and reporting standards.

• Manage investigator and site payment processes.

• Guide the project team in preparing for study audits and inspections, including addressing any findings.

• Participate in regional project oversight for APAC as required.

⛳️ 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 experience in site monitoring.

• At least 2 years of experience in a Lead Monitor role.

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

• Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications is preferred.

• Strong communication, presentation, and customer service skills.

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

• Full working proficiency in English.

• Proficiency in MS Office applications, including MS Project.

🏝️ Benefits

• Remote work options available.

• Opportunities for professional development and investment in career success.

• A stable and secure workplace.

• An inclusive culture and welcoming environment.