Risk Quality Management; RBQM Specialist

Why consider this job opportunity

• Salary up to $
• Opportunity for career advancement and growth within the organization
• Comprehensive health benefits, including medical, dental, and vision insurance
• Generous time off policy, including paid vacation, sick leave, holidays, and parental leave
• Supportive resources for employee wellness, including financial wellness tools and emotional well-being support
• Collaborative and innovative work culture that values unique contributions

• Support Clinical Trial Teams in developing Risk Assessment and Mitigation Plans, identifying critical-to-quality factors, and defining monitoring strategies
• Conduct centralized monitoring of Key Risk Indicators and data quality signals; elevate trends and partner with teams to define mitigation actions
• Collaborate with RBQM vendors to ensure the implementation of the selected RBQM model and maintain strong oversight
• Review and approve trial-specific RBQM documentation for alignment with frameworks and standard operating procedures
• Facilitate the adoption and understanding of RBQM practices and support training for internal and external stakeholders

• Minimum of a bachelor’s degree and 8-10 years of relevant experience in biotech or pharmaceutical companies
• Proven experience in planning and executing RBQM activities in collaboration with Clinical Trial Teams
• Experience guiding teams in identifying critical data and processes, performing risk assessments, and developing monitoring plans
• Understanding of clinical development and trial conduct, including GCP and ICH guidelines
• Strong communication skills and the ability to solve problems and make decisions

• Experience in collaboration with clinical Contract Research Organizations regarding monitoring strategies
• Strong analytical skills with the ability to interpret and present data
• Familiarity with oncology or a strong willingness to learn about oncology
• Experience in process development and quality mindset
• Previous leadership experience in RBQM strategy and initiatives

#Biotechnology #Clinical Trials #Risk Management #Career Opportunity #Innovative Culture

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