Manager, Phase I Clinical Research Unit / CIM (Research Institute)
Manager, Phase I Clinical Research Unit / CIM (Research Institute)
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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 Qubec - Sant (FRQS).
Position summary
The Centre for Innovative Medicine 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 the research team and assures the successful completion of Phase I clinical trials. Develops partnerships and involved in the business development between The Institute and external sponsors. Creates budget plans and oversees the operating budgets of each of the Phase I 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.
Oversees and manages personnel and/or consultants in the Phase I studies. Independently handles multiple study assignments and interacts with internal departments and external resources.
Participates in initiatives to develop and administer training in clinical trials to diverse audiences inside and outside of the institution.
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 I Unit. 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 Consortiums and Committees.
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 the Phase 1 Team to oversee study performances and discuss issues
Meets with CIM Director 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 Phase 1 Trials to review clinical activities challenges reports
Participate in annual scientific meetings monthly Disease Site meetings applicable consortiums
Oversee staff performance reviews
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 clinical research
May be involved in specific projects as requested by the CIM Director of Operations and CIM Medical Director of Phase 1.
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 1 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 Institute
Ensure compliance with regulatory guidelines and quality standards
Ensure research participant safety at all-time within the CIM.
Required Skills
Experienced in managing clinical trials with strong knowledge of federal provincial and international regulations (including ICH-GCP)
Demonstrates leadership in coaching and mentoring with solid project management and analytical skills
Known for effective communication presentation and organizational abilities with a capacity to manage multiple priorities in a fast-paced environment
Proficient in maintaining accurate records and experienced with electronic data systems (EDC CTMS). Background in business administration or project management is considered an asset
Experience with foreign regulatory agencies is highly valued.
Additional information
Status : 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. Management position requiring frequent overtime. May have to supervise different shifts (day night weekend)
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!
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
Required Experience:
Manager
Employment Type
Full-Time
