Manager, Monitoring & Site Management

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

📋 Description

• Plan, manage, organize, evaluate, and report on the daily operations of the Clinical Monitoring unit.

• Develop and enhance policies and procedures.

• Supervise product quality, site monitoring, compliance oversight, resource planning for staff, and performance management of both staff and contractors.

• Support and represent project and clinical monitoring teams to sponsors and researchers throughout the project lifecycle.

• Ensure that team members and third-party providers deliver high-quality and timely services in accordance with corporate standards, industry best practices, and regulatory requirements.

• Identify, develop, plan, monitor, approve, and report on project-specific processes and services concerning site selection, clinical monitoring, resolution of ICH-GCP compliance issues, global project harmonization, SOP and QS document maintenance, site visits, and IT collaboration.

• Represent and assist Clinical Monitoring teams with internal stakeholders and external sponsors to enhance services, address issues, and integrate technologies and processes.

• Manage the staffing, workload distribution, resource planning, training, development, technology, process enhancement, expenses, engagement, and performance of the Clinical Monitoring team.

• Identify, procure, and oversee independent contractor services for Clinical Monitoring, which includes recruitment, contract negotiations, compliance, training, cost monitoring, and performance management.

• Provide expertise in clinical, site, and compliance monitoring, and develop tools to support project teams and business development from bidding through sponsor reporting.

⛳️ Requirements

• College Diploma or University Degree in a relevant discipline (preferably Health Sciences or Life Sciences, or SoCRA and/or ACRP Certification/Designation).

• A minimum of 4–6 years of related experience.

• Continuous professional development through substantial ongoing training.

• Experience in managing CRA staff.

• Ability to provide training and mentorship to colleagues on a one-on-one basis or in group settings.

• Capability to work in a remote global environment.

• Strong understanding of regulations and guidelines related to clinical monitoring and GCP.

• A customer-service-oriented and solution-focused mindset.

• Demonstrated leadership abilities.

• Excellent verbal, written, and organizational skills.

• Ability to manage multiple tasks and meet deadlines in a fast-paced environment.

🏝️ Benefits

• Bonus.

• Home-based work / remote global capacity.