Manager, Oncology Clinical Research Unit (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 Québec - Santé (FRQS).

Position Summary

The Centre for Innovative Medicine (CIM) is an academic Clinical Research Unit (CRU) providing a variety of services to over 250 investigators and industry partners in order to facilitate the conduct of clinical studies.

Reporting to the CIM Director of Operations and following established institutional policies and governmental guidelines and regulations, the incumbent maintains organizational effectiveness, provides leadership and expertise to a large growing research team, assures the successful completion of Phase II-III oncology clinical trial studies, associate member of major Oncology Groups (Canadian Cancer Trials Group (CCTG), McPeak-Sirois Quebec consortium).

The incumbent will develops partnerships and involved in the business development between The Institute’s Oncology department and external sponsors. Creates budget plans and oversees the operating budgets of each of the Phase II-III units, oversees more than 75 study accounts at one time. Prepares reports and presentations, Determines new procedures and ensures that processes and documents are managed in accordance with Standard Operating Procedures (SOPs), ICH /GCP guidelines, as well as other regulatory requirements.

General Duties

Clinical

• Responsible for the management of specialized clinical trials, delivery of quality studies and related processes (i.e. staff qualification & training, checks & balances, budget, timelines, metrics and milestones);
• Oversees the operational budgets and accounts for Phase II/III Units. Generates the annual operational and salary budgets for each of the units;
• Monitors and ensures adequate oversight of clinical research activities is conducted;
• Develops timelines and tracks progress of clinical research activities;
• Communicates and presents study results and program issues to project team and other key internal stakeholders;
• Identifies and initiates discussions with investigators for PI initiated studies as well as those sponsored by industry;
• 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 (budget specialist, CIM Director of operations, staff, etc.);
• Ensures appropriate resources and priorities are maintained for the assigned projects conducting staff ratios and complexity of trials;
• Develops relationships with clinical research investigators, internal departments and industry partners;
• Improve overall collaborations to improve efficiency with the various groups (i.e., pharmacy, imaging, labs, pathology, etc);
• Interacts with as a member of key Oncology Consortiums and Committees; Canadian Cancer Trials Group (CCTG), McPeak-Sirois Breast Group as necessary.
  
  

Administrative/HR/Training

• Prepares analysis reports, key performance indexes on accrual lists (monthly, investigator, disease sites, coordinators, infusions, trials, start of study to first patient enrolled and other as applicable) and other important information for senior management;
• 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;
• Meets weekly with Supervisor(s) to oversee study performances and discuss issues;
• Meets with CIM Director of Operations on a bimonthly basis and report start-up delays, recruitment targets, QA audit/monitoring issues, and other updates;
• Meets bi-monthly with CIM Medical Director of Oncology Trials to review clinical activities, challenges, reports;
• Participate in annual scientific meetings, monthly Disease Site meetings, applicable consortiums;
• Oversee staff performance reviews as prepared by the Supervisors;
• Conduct staff performance reviews of Supervisors;
• Participate and promote in the development of staff training:
• New staff;
• Encourage ongoing training for the team and internal groups to enhance the conduct of oncology clinical research.
• May be involved in specific projects as requested by the CIM Director of Operations and CIM Scientific Director of Oncology.
  
  

Education And Training

• Participates to the development and implementation of training initiatives that target diverse audiences inside and outside of the institution as appropriate;
• Offers content expertise to the development of new curricula;
• Acts as a subject matter expert for training diverse audiences;
• Creates the conditions for experiential learning opportunities within Oncology research.
  
  

Budget Review

• Responsible for the management of his/her operational budgets for Phase II-III Units within stated financial goals and implement actions to maximize cost-recovery;
• Oversees in the management of study budgets for each investigator and provides yearly financial clinical trial report to each of the investigators and disease sites to monitor trial financial activities;
• Implements 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 utilization of clinical research infrastructure;
• Develop services and infrastructure to respond to researchers’ and partners’ needs;
• 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

https://rimuhc.ca/en

Education / Experience

Education: Bachelor's Degree

Field of Study: Bachelor degree in a relevant discipline. Master’s or PhD is an asset.

Work Experience: Minimum of 5 to 7 years’ experience in a pharmaceutical/biotechnical or related environment, a minimum of 2-3 years of experience supervising employees is required.

Required Skills

• Excellent knowledge and/or training in international, federal, and provincial laws and regulations governing clinical research, including ICH-GCP; this knowledge is considered a strong asset;
• Training in business administration or project management considered an asset;
• Must demonstrate leadership abilities and experience in managing, coaching and mentoring;
• Direct experience in managing clinical trial studies, including risk assessment and contingency planning;
• Excellent presentation skills;
• Proficient project management skills;
• Excellent ability to generate and maintain accurate records;
• Analytical thinker with excellent problem solving;
• Flexible and ability to work independently and collaboratively, as required in a fast-paced environment;
• Excellent communication, planning, organizational and time management skills including the ability to support and prioritize multiple projects;
• Experience working with electronic data management systems, tools and technologies (EDC) is an asset;
• Experience working with Clinical Trial Management System (CTMS) is an asset;
• Experience in dealing directly with other foreign regulatory agencies is highly desired;
• Excellent verbal and written communications skills.
  
  

Additional information

Status : Full time (35 hours/week)

Pay Scale: $69,851.60 - $129,729.60. Commensurate with education & work experience.

Work Shift: Monday to Friday between 8:30am to 4:30pm

Work Site: GLEN Site, 1001 boul. Decarie

***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!
  
  

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, [email protected]