Senior Study Start-Up Specialist

BeiGene

1d

About The Position

BeOne is a global oncology company dedicated to discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, the company expedites the development of its diverse pipeline of novel therapeutics through internal capabilities and collaborations, committed to radically improving access to medicines for far more patients who need them. The growing global team consists of more than 11,000 colleagues spanning six continents. The Senior Study Start-Up Specialist is responsible for the delivery of study start-up, initial and ongoing submissions within established timelines, ensuring high quality and adherence to ICH/GCP, BeOne’s SOPs, and local regulations. BeOne values Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit.

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

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

Benefits

• Eligible to participate in the annual bonus plan (for Non-Commercial roles)
• Eligible to participate in an incentive compensation plan (for Commercial roles)
• Opportunity to own shares of BeOne Medicines Ltd. stock
• Eligible for discretionary equity awards
• Voluntary participation in the Employee Stock Purchase Plan
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior