Study Start-Up Specialist

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 Israel 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
  
  

• 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) or support CTIS Submission
• 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 Study 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.
• Initiate, support or lead process improvement initiatives
  
  

• 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 Hebrew and English (writing and speaking)
• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
  
  

• 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