Senior Study Start-Up Specialist

About the role

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.

Responsibilities

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
• Contribute to discussions during the feasibility stage 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

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

Global Competencies

• 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

Pay

Salary Range: $83,800.00 – $113,800.00 annually. Actual compensation packages are determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.

Benefits

• Annual bonus plan eligibility (Non-Commercial roles)
• Incentive compensation plan eligibility (Commercial roles)
• Eligibility for discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan
• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness