The Manager, Monitoring & Site Management is responsible for the day-to-day leadership and delivery of the Clinical Monitoring function, with responsibility for Clinical Operations Leads and associated contractor resources. This role oversees resource planning, staff development and performance, clinical monitoring quality, regulatory compliance, process improvement and operational delivery. Working closely with project teams, sponsors and internal stakeholders, the Manager provides clinical monitoring expertise throughout the project lifecycle and ensures services are delivered to a high standard, on time and in accordance with regulatory requirements, industry best practices and organizational objectives.
Responsibilities
Lead the day-to-day delivery of the Clinical Monitoring function, ensuring high-quality, timely and compliant services across assigned projects; Manage and develop Clinical Operations Leads, including resource planning, work allocation, training and development, employee engagement and performance management; Ensure appropriate staffing levels across projects, balancing operational requirements, team capacity and project priorities; Partner with clinical monitoring and project leadership to develop and oversee project-specific strategies and processes relating to site selection, monitoring, ICH-GCP compliance and global project delivery; Provide oversight and support for the identification, escalation and resolution of site, sponsor and clinical monitoring issues; Drive the development and continuous improvement of policies, procedures, tools and processes supporting Clinical Monitoring activities; Partner with internal stakeholders, sponsors and research sites to identify opportunities for improvement and support the implementation of new technologies and processes; Identify, engage and manage independent contractor resources, including recruitment, contract support, training, cost monitoring, compliance and performance management; Ensure Clinical Monitoring activities comply with applicable regulations, ICH-GCP, organizational procedures and industry best practices; Provide Clinical Monitoring expertise to project teams and Business Development throughout the project lifecycle, from the bidding process through project delivery and reporting to sponsors
Requirements
College diploma or university degree in a relevant field, preferably Health Sciences or Life Sciences; Minimum 4–6 years of relevant clinical research/clinical monitoring experience with substantial ongoing training; Demonstrated experience managing CRA or Clinical Monitoring staff, including performance management, resource planning and staff development; Proven ability to train, mentor and support colleagues in both one-to-one and team settings; Strong knowledge of ICH-GCP, applicable clinical research regulations and guidelines, and clinical monitoring best practices; Demonstrated leadership skills with the ability to engage, develop and support high-performing teams; Strong stakeholder management skills and a collaborative, customer-focused and solution-oriented approach; Strong verbal and written communication skills, with the ability to work effectively with internal teams, sponsors and external partners; Excellent organisational and prioritisation skills, with the ability to manage multiple responsibilities and deadlines in a dynamic environment; Ability to work effectively in a remote, global environment and collaborate across functions, geographies and time zones
Nice to have
SoCRA and/or ACRP certification/designation
Benefits
Education Reimbursement program for full-time employees; Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility); One time office setup allowance (can be used to purchase a scanner/printer, extra monitor, office furniture, etc.); Working while visiting program – up to 4 weeks per year; Flexible Summer Hours Program from May – September; Employee referral incentive; Full-time employees also become beneficiaries of the Alimentiv Trust after one year of employment, and permanent members after 5 years of employment; Optional formal mentorship program (Alimentorship); country/region annual social events in person; leadership development programs for people leaders in accordance with seniority; social committee and several other optional initiatives
Kanada · Toronto
