Clinical Research Manager

RI-MUHC | Research Institute of the MUHC | #rimuhc; Montreal (administrative region); On-site; CAD 72,000 - 133,000; Full time

Benefits offered by this job

4-week vacation

Paid holidays

Pension plan

Job summary

RI-MUHC is seeking a Clinical Trial Project Manager to oversee operational management of multicentre clinical studies in Montreal. You will lead start-up, site activation, regulatory submissions, monitoring, recruitment, and study logistics, collaborating with sponsors, investigators, and data teams.

The role requires managing risk-based quality oversight, safety reporting, and regulatory inspections while coordinating with MUHC and external sites.

Qualifications

• Bachelor's degree in sciences or related field.
• Minimum 2 years of experience in multicenter study management.
• Fluent in French with advanced English; complex communications with researchers.
• Experience with ICH-GCP and Health Canada regulations preferred.

Responsibilities

• Oversee study start-up and site activation.
• Coordinate regulatory submissions and CTAs, site agreements and budgets.
• Monitor recruitment performance and provide site support.
• Coordinate central monitoring and risk-based quality oversight.
• Ensure safety reporting and regulatory compliance across sites.

Skills

French proficiency

Advanced English

Budget management

Project coordination

Regulatory knowledge

Multicenter trials

Education

Bachelor's degree in sciences or related field

Tools

EDC

MS Excel

PowerPoint

Quality systems

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 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 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, 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 training and maintain oversight of training requirements.
• Support sites during regulatory inspections, audits, and other quality assessments.
• Ensure regulatory and study documentation remains current and compliant throughout the study.
• Data Management and Study Systems
• Provide operational oversight of study EDC, randomization, and other study platforms, including access and issue resolution.
• Collaborate with the Database/Data Manager to monitor data quality and identify outstanding data issues.
• Review data management reports and coordinate periodic queries with study coordinators to ensure timely resolution.
• Perform or coordinate remote data quality checks and follow up on identified issues.
• Partner with Data Management and Biostatistics to support data cleaning, analyses, reporting, and study deliverables.
• Biospecimen, Laboratory, and Pharmacy Oversight
• Oversee the collection, handling, processing, shipment, and tracking of study biospecimens.
• Coordinate transfer of biospecimens to the Biobank and designated central laboratories.
• Liaise with local and central laboratories regarding shipments, processing requirements, discrepancies, and operational issues.
• Provide operational oversight of pharmacy activities and Investigational Product (IP) management, including availability, storage, accountability, and reconciliation, as applicable.
• Study Governance and Stakeholder Coordination
• Coordinate study governance meetings, including DSMC, Oversight Committee (OC), Steering Committee (SC), and other study meetings.
• Prepare agendas, presentation materials, action items, and minutes.
• Track decisions, risks, and action items through completion.
• Maintain effective communication among the Sponsor, investigators, sites, vendors, laboratories, data management, biostatistics, and other study partners.
• Support knowledge mobilization and communication of study findings with relevant partners and stakeholders.
• Support grant applications and activities related to securing future funding.
• Financial and Site Payment Management
• Monitor site budgets, payments, and outstanding financial obligations.
• Coordinate budget revisions and financial follow-up with participating sites and relevant institutional or Sponsor representatives.
• Support reconciliation of site payments and study-related financial obligations.
• Trial Master File and Documentation
• Manage and maintain the study Trial Master File (TMF), ensuring essential documents are complete, current, and appropriately filed.
• Support sites in maintaining appropriate Investigator Site Files (ISFs).
• Coordinate document collection, reconciliation, and filing throughout the study lifecycle.
• Study Close-Out and Archiving
• Oversee site close-out activities and ensure completion of outstanding documentation, data queries, IP activities, biospecimen activities, and financial obligations.
• Review site closure reports and follow up on outstanding items.
• Ensure appropriate study archiving in accordance with regulatory, institutional, and Sponsor requirements.
• Support final reconciliation of study documentation and essential records.
• Project Management
• Maintain study timelines, milestones, risk registers, action-item trackers, and operational plans.
• Identify and elevate study risks, operational issues, dependencies, and potential delays.
• Coordinate cross-functional activities to ensure study deliverables are completed on time and according to requirements.
• Provide regular study status updates to study leadership and the Sponsor.
• Contribute to continuous improvement of study processes, tools, and workflows.
• Perform other related duties as assigned by the supervisor.

Website of the organization

https://rimuhc.ca/en

Education / Experience

Education: Bachelor's degree

Field of Study: Sciences or other related to position

Work Experience: 2 years of experience in multicenter study management Experience in the pharmaceutical industry combined with hospital environment is preferred

Required Skills

• Knowledge of French is required.
• An advanced knowledge of oral and written English is required, as the position requires regular and complex contact with researchers or international students who are exclusively proficient in English. The position also requires complex writing or in-depth analysis of documents in English related to a research project.
• Working knowledge of project and budget management,
• Clinical research accreditation is preferred,
• Excellent organizational skills,
• Ability to manage multiple priorities, prioritize for time-sensitive issues, and work under minimal supervision,
• Excellent knowledge of international, federal and provincial laws and regulations governing clinical research (ICH-GCP),
• Self-directed and organized. Able to work both independently and as part of a team,
• Excellent interpersonal skills,
• Proficient with technology systems (EDC, MS Excel, PowerPoint, etc.).
• Experience with Health Canada Regulated Trials.

Status

Temporary, full time (35-hour workweek)

Pay Scale

71,598.80$ - 132,969.20$Commensurate with education and experience

Work Shift

Monday to Friday 8:30am to 4:30pm

Work Site

Glen Site, 1001 Decarie Blvd.

Why work with us?

• 4-week vacation, 5th week after 5 years,
• Bank of 12 paid days (personal days and days for sickness or family obligations),
• 13 paid statutory holidays,
• Modular group insurance plan (including gender affirmation coverage),
• Telemedicine,
• RREGOP (defined-benefit pension plan)
• Training and professional development opportunities,
• Child Care Centres,
• Corporate Discounts (OPUS + Perkopolis),
• Competitive monthly parking rate,
• Employee Assistance Program,
• Recognition Program,
• Flex work options and much more!

https://rimuhc.ca/careers

To learn more about our benefits, please visit http://rimuhc.ca/en/compensation-and-benefits

THIS IS NOT A HOSPITAL POSITION.

Equal Opportunity Employment Program

The Research Institute of the McGill University Health Centre hires on the basis of merit and is strongly committed to equity, diversity and inclusion within its community. We welcome applications from all qualified candidates who self-identify as members of racialized groups/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and 2SLGBTQIA+ persons. We also welcome candidates with the skills and knowledge to productively engage with diverse communities. Persons with disabilities who anticipate needing accommodations for any part of the application process may confidentially contact, [e-mail]