Manager, Monitoring & Site Management (Canada)

Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour operational excellence and deep therapeutic expertise including supporting more than 70% of IBD compounds in development.
We operate as a private profit-with-purpose company channeling our commercial success back into scientific research technology and our people. With approximately 700 people across multiple countries and three service lines we are growing deliberately and the capability of our leaders and our organization is central to how we get there.

If you want to do meaningful work build something real and invest back in research that changes lives we want to meet you!

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.

• 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.

• College diploma or university degree in a relevant field preferably Health Sciences or Life Sciences; SoCRA and/or ACRP certification/designation is considered an asset.

• Minimum 46 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.