Regional Project Lead

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

📋 Description

• Optimize the operations of project teams to ensure uniformity of Clinical Operations processes throughout North America.

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

• Communicate study progress to clients and international stakeholders.

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

• Evaluate study status and progress; gather and convey project status updates.

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

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

• Manage study-specific and corporate tracking systems.

• Supervise site selection and initiation, contractual negotiations, and budget discussions.

• Guide project team and site training; conduct field training for monitors.

• Ensure adherence to project-specific training matrices.

• Oversee site selection, initiation, monitoring, and closeout visits.

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

• Manage investigator and site payment processes.

• Oversee preparations for study audits/inspections and resolution of any findings.

• Engage in regional project oversight for North America.

⛳️ Requirements

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

• A minimum of 4 years of experience in site monitoring.

• At least 2 years of experience as a Lead Monitor.

• Background in supervising clinical project activities and leading clinical project teams.

• Preferred experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications.

• Strong communication, presentation, and customer service abilities.

• Skills in team building, leadership, and organization.

• Full working proficiency in English.

• Proficient in MS Office applications, including MS Project.

🏝️ Benefits

• A stable and secure workplace.

• An inclusive culture.

• Investment in professional development and success.

• Option for remote work.