Unit Manager

4 weeks ago

Montréal, Canada Centre universitaire de santé McGill Full time

**Organization description**

Le Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l’échelle internationale pour l’excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d’assurer aux patients des soins fondés sur les connaissances les plus avancées dans le domaine de la santé et de contribuer au progrès des connaissances.

**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**
Our team is seeking a highly motivated person with a desire to lead a clinical trials’ program with international scope and reputation in a dynamic and friendly academic non-profit environment. Our unit is a recognized leader in the care of thoracic cancer patients, which services a large catchment area population of nearly 2 million. The goal of the position is to lead and manage this team with the specific goal of growing our network both regionally, nationally, and internationally. This will require close interaction with industry, as well as community hospitals and academic university-based health care teams.

**General Duties**
ROLE:

- Demonstrate leadership and expertise and assures the successful completion of clinical trial studies,
- Ensure that documents are managed in accordance with Standard Operating Procedures (SOPs), ICH /GCP guidelines, as well as other regulatory requirements,
- Oversee and manage personnel and/or consultants,
- Independently handle multiple study assignments and interact with internal departments and external resources. External resources include regional network hospitals where trial activities may be conducted and national and international partners in the context of multi-center studies.

SPECIFIC RESPONSIBILITIES:
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),
- 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,
- Leads regulatory interactions with Health Canada submissions,
- 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,
- Improves overall collaborations to ameliorate efficiency (pharmacy, Imaging, platform, ethics, etc.),
- Assesses project feasibility with the Principal Investigator and internal resources (budget specialist, staff, etc.),
- Develops relationships with clinical research investigators, internal departments, and industry partners,
- Improves overall collaborations to improve efficiency with the various groups (i.e., pharmacy, imaging, labs, pathology, etc.).

Administrative/HR
- Prepares analysis reports on accrual lists (monthly, investigator, disease sites, coordinators, infusions, trials, and others, as applicable),
- Is involved with the writing/reviewing procedures and documentation for the clinical research conducted,
- 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 with Supervisor(s) to oversee study performances and discuss issues and report start-up delays, recruitment targets, QA audit/monitoring issues, and other updates,
- Participates in annual scientific meetings, Disease Site meetings, applicable consortiums,
- Oversees staff performance reviews as prepared by the Supervisors,
- Conducts staff performance reviews of Supervisors.
- Participates in and promotes 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 Supervisors.

Budget review
- Is responsible for the management of his or her operational budget within stated financial goals and implement actions to maximize cost-recovery,
- Assists 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.

**Website of the organization**

**Education /

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