Clinical Research Manager

RI-MUHC | Research Institute of the MUHC | #rimuhc; Montreal; On-site; CAD 85,000 - 120,000; Full time

Job summary

RI-MUHC is seeking an experienced Clinical Trial Project Manager to oversee multicentre studies, including start-up, site management, regulatory compliance, and data coordination in Montreal. You will partner with sponsors, investigators, CRAs/Monitors, and labs to ensure timelines and quality.

You will lead onboarding, monitor recruitment, manage study logistics, and address operational risks in a fast-paced research environment dedicated to patient-centered medicine.

Qualifications

• Experience in multicentre clinical research start-up and site activation.
• Strong knowledge of regulatory requirements and submissions (REB/Nagano).
• Budget planning, revisions, and coordination with sponsors and sites.

Responsibilities

• Oversee study start-up, site activation, and regulatory documentation for multicentre studies.
• Coordinate preparation and follow-up of CTAs, Site Agreements, budgets, and revisions.
• Manage site regulatory submissions and follow-up queries and amendments.

Skills

Study Start-Up

Site Activation

Regulatory Submissions

Budget Management

Stakeholder Coordination

Clinical Monitoring

Data Management

Multicentre Trials

Job description

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 lift 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 on-site 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,