Clinical Research Project Manager (Research Institute)

Clinical Research Project Manager (Research Institute)

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!

Position Summary
Under the supervision of the Study Principal Investigator, and following established governmental guidelines and regulations, the incumbent is responsible for the management of a multicentre clinical research study.

General Duties

• Develop manuals, supervise safety reporting, train staff and interact remotely with CHUM and HMR personnel.
• Oversee site activities, including obtaining consent and administering questionnaires, and nurses administering vaccines and collecting bio specimens in all satellite clinics at the MUHC and external sites.
• Ensure bio specimens are transferred for processing and storage in the Biobank and, periodically, to central laboratories.
• Partner with the data manager (CORD) and biostatistician (BCU) for analyses and reporting.
• Manage knowledge mobilization with partners.
• Perform Site Qualification (if applicable).
• Prepare and manage sites CTAs/Site Agreements (includes budget revision/negotiation).
• Prepare and manage sites Regulatory documents for site start-up (PSP, QIU, CTSI).
• Prepare study material for Sponsor (Study Reference Manual, EDC manual, study logs, etc.).
• Conduct REB- Nagano submission and follow-up (Multicenter).
• Follow-up with the site on the recruitment target.
• Prepare and manage payment to sites, if applicable.
• Conduct status meetings with Sponsor Team, Vendors, and study sites.
• Maintain communication with Recruitment Sites via phone and email to provide support and assist in identifying and resolving recruitment-related issues.
• Review reports of Site Closure activities.
• Oversee Study EDC platform, Randomization platform & pharmacy (IP).
• Oversee site concerns and questions.
• Support site if inspected or audited.
• Manage study Trial Master File (TMF) - sites manage their own (ISF).
• Ensure site close-out and archiving are performed.
• Complete remote spot checks for data capture accuracy.
• The Database Manager will provide reports to the PM and the PM will send queries quarterly to study coordinators.
• Set up all study meetings (i.e. DSMC, OC, SC) with agenda, slides, and provide minutes.
• Oversee all study logistics with Central and local Labs, study equipment, Vendors, Database access and issues.
• Other duties as assigned by the supervisor.

Education / Experience
Education: Bachelor’s degree in Health Science or a related field.
Work experience: A minimum of 2 years’ experience in multicenter study management.

Required Skills

• Bilingual (excellent verbal and written communication skills in French and English).
• Working knowledge of project and budget management.
• Experience in the pharmaceutical industry combined with hospital environment is preferred.
• 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: Commensurate with education and experience. $54,327.00 - $100,882.60.
Work Shift: from 8:30 a.m. to 4:30 p.m., Mondays to Fridays
Work Site: Glen site (1001 Decarie Blvd.)

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

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 government 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!

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 research.talent@muhc.mcgill.ca