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 start-up activities in Germany and Austria and provides local expertise.
• Identify gaps and areas for improvement and propose CAPA.
• The Start-up specialist is responsible for collaborating closely with the Regional Clinical Study Manager/Start-up Lead to ensure study timelines are adhered to and required quality standards are maintained.
• CRA experience is considered a plus

SSUS activities

• Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiations
• Retrieves essential documents from study site and performs essential document site file reconciliation. Perform independent quality review of submission packages, submit package to EC (and HA), if required.
• Review and translate drug labels, ICF, site specific recruitment materials and other applicable documents.
• Manages sites and site performance by tracking regulatory submissions and relevant milestones

• Ensure inspection readiness of start-up study and site documentation
• Collaborates with Regional Clinical Operations Manager/ Start-up Lead and clinical study sites to ensure timely delivery of start-up milestones

• Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.

• Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation.

Sr. SSUS responsibilities

• Mentor and manage junior SSU staff
• Acts as the escalation point person for SSUS(s) with site related issues and concerns
• May serve as subject matter expert for clinical operations, country regulations and SSU-related activities.

Qualifications:

• BS or equivalent in a relevant scientific discipline
• Experience in oncology global trials preferred
• Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
• 2-5 years of Start-up experience in the pharmaceutical or CRO industry
• Excellent communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Fluent in German is a must
• English (writing and speaking)
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook

Travel: up to 15%

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

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.