Manager, CIM Start Up and Regulatory (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!

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 Qubec - Sant (FRQS).

Position summary
The Centre for Innovative Medicine is a world class academic Clinical Research Unit (CRU) with technical platforms providing a variety of services to over 250 investigators and industry partners in order to facilitate the conduct of clinical studies.

Under the supervision of the CIM Director of operations the incumbent must demonstrate leadership expertise and ensures the startup of clinical trials and ongoing regulatory activities meet the needs and requirements of the PI sponsor and CIM. The incumbent ensures to carry out the mission vision and objectives of the RI-MUHC as well as applicable guidelines.

Manages personnel and oversees the operations of the Start Up and Regulatory group users and/or internal and external clients. Manages projects and interacts with internal and external departments and resources.

General Duties
The CIM Start Up and Regulatory includes:

Ethics submissions of trials new and amendments throughout the duration of a trial
Approve budget proposals prepared by the Budget group before they are presented to the sponsor/CRO
Establish all necessary service agreements with internal and external departments that will provide services during the course of the trial
Ensure all training and documentation in place to enable the conduct of the trial
Ensure contracts are completed and signed
Manage SSV SIV site activation in conjunction with the CIM team and PI that will run the trial
Work with other Managers to ensure standards are met
Key point of contact for CATALIS.

Clinical:
Approve budget proposals prepared by the Budget group before they are presented to the sponsor/CRO
Responsible for the efficient startup of all new clinical trials and the revision as necessary of ongoing trials
Monitors and ensures adequate oversight of content expert staff engaged in these activities
Develops timelines and tracks start up times
Communicates metrics to key internal stakeholders
Identifies and initiates discussions with investigators for potential studies
Acts as the point-of-contact for all sponsor inquiries and leads the resolution of issues
Improve overall collaborations to improve efficiency (pharmacy Imaging platform ethics etc.)
Assess project feasibility with the Principal Investigator and internal resources
Ensures appropriate resources and priorities are maintained for the assigned projects
Develops relationships with clinical research investigators internal departments and industry partners
Improve overall collaborations with CATALIS.

Administrative/HR:
Prepares analysis reports
Involved with the writing/reviewing procedures and documentation for clinical research conducted at the CIM
Monitors compliance and applicable regulations concerning clinical research activities
Complies reviews and addresses issues ensures corrective and preventative action plan is taken as needed
Meet with CIM Director of Operations and report start-up delays recruitment targets QA audit/monitoring issues and other updates
Participate in annual scientific meetings Disease Site meetings applicable consortiums
Conduct staff performance reviews
Participate and promote in the development of staff training:
oNew staff
oEncourage ongoing training for the team and internal groups to enhance the quality of start up activities
May be involved in specific projects as requested by the CIM Director of Operations.

Budget Review:
Responsible for the management of his/her operational budget within stated financial goals and implement actions to maximize cost-recovery.

STANDARDS OF PERFORMANCE:
Maintain efficient and high quality support and service to clinical investigators and external partners
Ensure adequacy and optimal procedures maintained in startup of clinical trials
Promote and pursue development of clinical research at the RI MUHC
Ensure compliance with regulatory guidelines and quality standards
Ensure research participant safety at all-time within the CIM.

Website of the organization

/ Experience

Education: Bachelors Degree
Field of Study: . at a minimum. Masters or PhD. degree in a relevant discipline an asset.

Other education considered an asset for this position:
Certificate or diploma in business administration is an asset
Training in project management considered an asset
SoCRA accreditation is an asset.

Work Experience:
Minimum of 5 to 7 years experience in ethics regulatory. A minimum of 2-3 years of experience supervising employees is required.

Required Skills

Bilingual Expertise: Exceptional communication skills in both French and English (spoken and written)
Strong Interpersonal & Leadership Abilities: Proven experience in team leadership coaching and building collaborative relationships
Project & Time Management Pro: Skilled in juggling multiple priorities in a fast-paced environment with minimal supervision
Analytical Mindset: Strategic thinker with strong problem-solving and decision-making skills to support organizational success
Tech-Savvy: Hands-on experience with Nagano and adaptable to new tools and platforms
Research Regulatory Awareness: Familiarity with ICH-GCP and research regulations at the international federal and provincial levels (an asset)
Flexible & Team-Oriented: Comfortable working independently or within cross-functional teams open to evolving responsibilities
Partner Relations: Ability to maintain strong connections with external sponsors and internal partners (e.g. Research Ethics Office MUHC divisions Administration DPS etc.).

Additional information

Status : Temporary Full Time (35-hour workweek)
Pay Scale: Commensurate with education & work experience. $69851.60 - $129729.60.
Work Shift: Monday to Friday between 8:30am to 4:30pm 7 hours per day 5 days per week. Management position requiring frequent overtime.
Work Site: GLEN Site 1001 Dcarie and MGH site 1650 Cedar.

***Please make sure to include a cover letter and 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
PPMP (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!


learn more about our benefits please visit 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