Clinical Operations Project Manager
4 weeks ago
Job Summary:
The University of Saskatchewan is seeking a highly skilled Clinical Operations Project Manager to join our team. As a key member of our Clinical Trials Team, you will be responsible for providing expert support and guidance to our clinical trial support unit.
Key Responsibilities:
- 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 logistical 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
Requirements:
- A degree in Health sciences or related discipline is preferred/would be an asset
- 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
Preferred Qualifications:
- 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
Working Conditions:
The successful candidate will work in a fast-paced environment with multiple priorities and deadlines. The ability to work independently, take initiative, and anticipate future needs, issues, and events is essential.
How to Apply:
Applications should be submitted online at [insert link]. We thank all applicants for their interest; however, only those selected for an interview will be contacted.
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