General Description:
- Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Essential Functions of the job:
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Contribute to discussions during the feasibility state of site selection
- Site Start-Up
- Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
- ICF/Submissions
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
- Skilled in document preparation and submission to central IRB to ensure timely reviews.
- Ensure collection and review of essential documents
- Complete SSU data entry in CTMS
- Complete timely and quality eTMF filing
- Support in the development of local workflows to streamline output and deliverables.
- Contribute to the ongoing improvement of SSU infrastructure in North America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals.
Supervisory Responsibilities:
Education/Experience Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
Salary Range Canada:
- 76,000.00 CAD - 95,000.00 CAD
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
