Study Start-Up Specialist

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:
Support in the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene 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.
Support in the 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:
Not applicable

Education/Experience Required:
Bachelor’s degree or higher degree in a scientific or healthcare discipline preferred with minimum of 2 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Salary Range Canada:

·         69,100,000.00 CAD -86,400.00 CAD
Please note that this job posting is being advertised to fill a budgeted position.

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

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.