Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and make a difference

Job Description

RESEARCH INSTITUTE OF THE MUHC

The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position Summary

Under the supervision of the Study Principal Investigator and following established governmental guidelines and regulations, the Clinical Trial Project Manager is responsible for the operational management of multicentre clinical research studies. The Project Manager oversees study start-up, site management, monitoring, recruitment, regulatory and safety activities, data and study systems, study logistics, stakeholder coordination, and study close-out. The role works closely with the Sponsor, investigators, CRAs/Monitors, study teams, data management, biostatistics, laboratories, and other study partners to ensure that study activities are conducted in accordance with the protocol, applicable regulations, institutional requirements, and study timelines.

General Duties

- Study Start-Up and Site Activation
- Prepare and manage site Clinical Trial Agreements (CTAs), Site Agreements, budgets, and budget revisions,



including negotiation and follow-up.
- Coordinate site regulatory and start-up documentation, including PSP, QIU, CTSI, and other applicable requirements.
- Conduct and coordinate multicentre REB/Nagano submissions and follow up on approvals, queries, and amendments.
- Conduct Site Qualification activities, as applicable.
- Develop and maintain study manuals, reference materials, procedures, and study-specific tools required for site implementation.
- Site and Study Management
- Provide operational oversight to participating sites, including MUHC satellite clinics and external sites such as CHUM and HMR.
- Coordinate site responsibilities and study procedures, including informed consent, questionnaires, vaccination, biospecimen collection, and other protocol-required activities.
- Monitor recruitment performance against study targets and support sites in identifying and resolving recruitment barriers.
- Maintain oversight of study logistics, including equipment, supplies, laboratory coordination, vendors, and site-specific operational requirements.
- Address site questions and operational issues and elevate significant risks or issues to study leadership and the Sponsor.
- Conduct regular study status meetings with Sponsor teams, investigators, vendors, and study sites.
- Co-Monitoring




- Participate in in office and remote co-monitoring visits with assigned CRAs/Monitors.
- Support preparation, conduct, documentation, and follow-up of monitoring visits.
- Assess protocol compliance, informed consent, source documentation, data quality, safety reporting, investigational product management, and essential document maintenance.
- Review monitoring reports and track findings, protocol deviations, data discrepancies, and corrective and preventive actions through resolution.
- Support site-specific action plans and escalation of significant or recurring findings.
- Central Monitoring and Risk-Based Quality Oversight
- Coordinate and perform central monitoring using clinical, operational, safety, recruitment, and data-management metrics.
- Review dashboards, data listings, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and other risk-based monitoring metrics, as applicable.
- Identify trends, anomalies, data quality concerns, and potential site-level risks requiring further review or targeted monitoring.
- Coordinate investigation and follow-up with CRAs, study coordinators, Data Management, Biostatistics, Safety, and other relevant teams.
- Document central monitoring findings and track identified risks through resolution.
- Support the development and periodic review of the study's risk-based monitoring strategy.
- Safety and Regulatory Oversight
- Oversee safety reporting activities and ensure applicable safety information is communicated to the REB and DSMC within required timelines.
- Support sites in the identification, documentation, and resolution of safety-related issues.
- Ensure appropriate study staff train

📌 Clinical Research Manager (Montreal)
🏢 Research Institute of the McGill University Health Centre
📍 Montreal