Senior Study Start-Up Specialist

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. 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:

• 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 SOPs, and local regulations.

Essential Functions of the job:

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
• Site Feasibility
  • Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed.
  • Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
• Site Start-Up
  • 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.
• 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
• 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

Computer Skills:   Intermediate skils in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

Qualifications:   

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred
• Minimum of 4 years w/BA or 6+ w/o 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
• Effective prioritization of tasks in the achievement of goals
• Strong written and verbal communication skills
• Highly organized
• Diligence in follow through

Travel:  Up to 10%

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

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. 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.