Clinical Research Manager

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!

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
1. 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.

2. 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 escalate significant risks or issues to study leadership and the Sponsor.
Conduct regular study status meetings with Sponsor teams investigators vendors and study sites.

3. 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.

4. 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 studys risk-based monitoring strategy.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. Project Management
Maintain study timelines milestones risk registers action-item trackers and operational plans.
Identify and escalate 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.

/ Experience

Education: Bachelors 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

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: 71598.80$ - 132969.20$Commensurate with education and experience
Work Shift: Monday to Friday 8:30am to 4:30pm
Work Site: Glen Site 1001 Decarie Blvd.


***If you wish to include a cover letter please attach it with your resume in one document. ***

Why work with us

5-week vacation 6th 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
RRPE
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!



learn more about our benefits please visit IS NOT A HOSPITAL POSITION.

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