Project Manager

4 months ago

Saskatoon, Canada University of Saskatchewan Full time

**Project Manager - Clinical Operations, College of Medicine**:
**Primary Purpose**:The Project Manager - Clinical Operations uses specialized knowledge of research regulations, institutional policy, and operational processes to provide expert support and guidance to the OVDR clinical trial support unit. The Project Manager - Clinical Operations will develop and maintain CTSU standard operating procedures, shape clinical trial guidance documents, and will provide study timelines and forecasting goals to maintain clinical research momentum. The Project Manager - Clinical Operations will ensure operations are efficient and effective, and that they harmonize with college, university, and SHA operations. The Project Manager - Clinical Operations will work in collaboration with the Research Finance Analyst in order to develop accounting and reporting practices to ensure the unit’s sustainability moving forward.

**Nature of Work**:Reporting to the Director of Research, the Project Manager - Clinical Operations is an integral part of a cohesive, cross-unit team focused on restructuring and realigning the CTSU. The position demands attention to detail, considerable intellectual capacity, and the ability to manage complex duties with a high level of precision. Adaptability to evolving environments, balancing competing deadlines, and effective communication skills are essential for success in this role.

**Accountabilities**:
**Leadership - 10%**
- Collaborate with the Research Director to create strategic plans and action plans for the Clinical Trials Team
- Ensure the achievement of strategic goals set for the Clinical Trials Team and address any arising barriers
- Act as the Clinical Trials representative on internal and external committees
- Identify strategic alliance partners and nurture sustainable relationships
- Oversee the on-boarding and facilitate the training of new team members as required
- Cultivate a culture of innovation within the Clinical Trials Team and promote teamwork and positivity

**Operations - 75%**
- Develop and maintain standard operating procedures and guidelines supporting CTSU functions and goals
- Manage study intake and business case cost/benefit analyses
- Oversee and approve budget negotiations performed by budget underwriters
- Monitor current study agreements to optimize and streamline practices for efficiency
- Collect, analyze, and synthesize data related to overall performance
- Work collaboratively with the research finance team to achieve clinical research sustainability
- Collaborate with OVDR Team members to support and achieve Clinical Trials team goals
- Identify and address logístical challenges
- Exercise decision-making and problem-solving to ensure priorities and deadlines are met and take initiative to move beyond completion of assigned tasks to plan for future changes or requirements
- Stay updated on all policies and procedures regarding Clinical Trials
- Provide research and administrative support to the CTSU undertaking other assigned research projects and tasks as required
- Manage CTMS database, seeking ways to improve and streamline record keeping and general operational functions
- Maintain relationships clinical research personnel and ethics boards that are key to operations
- Act as point person to identify needs, facilitate understanding, and build capacity in clinical research at the University of Saskatchewan

**Communications - 15%**
- Manage communication on behalf of the Clinical Trials team
- Develop and execute a communications plan, including targeted advertising of Clinical Trial team services
- Oversee website redevelopment to enhance communication effectiveness
- Facilitate communication among Clinical Trial clients, the research community, and key stakeholders
- Strengthen and maintain relationships with other Clinical Trial units across Canada
- Strengthen and maintain relationships with key stakeholders such as the SHA and the SCA

**Qualifications**

**Education**: A degree in Health sciences or related discipline is preferred/would be an asset. A combination of education and experience will be considered. Project Management Professional certification would be considered an asset.

Knowledge of applicable laws and regulations governing clinical studies, including the Canada Food and Drug Regulations, Tri-Council Policy Statement, Good Clinical Practice (GCP) guideline and other relevant ethical, medical, and scientific standards would be considered an asset.

**Experience**:A minimum of five years of experience in the field of health research administration is required. Experience working in a diverse and inclusive environment is required. Experience working with investigator-initiated studies as well as industry-driven, Health Canada-regulated clinical trials is preferred. Experience in clinical trial monitoring would be an asset.

**Skills**: Exceptional organizational skills with the proven ability to work on multiple projects with

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