Senior Study Start-Up Specialist

BeiGene

5d•$83,800 - $113,800

About The Position

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. 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.

Requirements

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.
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

Responsibilities

Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
Contribute to discussions during the feasibility state of site selection
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.
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.