Study Start-Up Specialist

BeiGene

108d • $71,400 - $96,400

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. 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.

Requirements

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred
• 3+ years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment
• Knowledge in the execution of clinical trials, understanding of ICH/GCP
• Prioritization of tasks in the achievement of goals
• Strong written and verbal communication skills
• Highly organized
• Diligence in follow through

Responsibilities

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
• Skilled in driving kick-off and completion of tasks from selection through activation
• 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
• Support in the collection and review of essential documents
• Complete SSU data entry in CTMS
• Support in the development of local workflows to streamline output and deliverables
• Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America
• Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness
• Annual bonus plan for non-commercial roles
• Incentive compensation plan for commercial roles
• Discretionary equity awards
• Employee Stock Purchase Plan

What This Job Offers

• Career Level: Mid Level
• Education Level: Bachelor's degree