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
Not applicable
Education/Experience RequiredBachelor’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 Canada76,000.00 CAD - 95,000.00 CAD
Global CompetenciesWhen 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
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents.
To learn more about BeOne, please visit and follow us on Linked In, X (formerly known as Twitter), Facebook and Instagram. For more information, please visit the link to explore job opportunities in China Mainland.
China Mainland Job Posting At Be OneAt BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
Patients First Driving Excellence Bold Ingenuity Collaborative Spirit
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