Risk Management Associate Director

3 weeks ago


San Mateo, California, United States BeiGene Full time

Job Summary:

The Risk Management Associate Director will oversee the creation of risk assessments for clinical development entities, follow up on quality signals and issues, and contribute to the advancement of the Risk-Based Quality Management (RBQM) program.

Key Responsibilities:

  • Provide onboarding training and tools to assigned teams to aid in the adoption of RBQM
  • Facilitate risk management with stakeholders to identify critical to quality factors, and identify, evaluate, control, communicate, review, and report risks
  • Collaborate with CRAs, Central Statistical Monitors, Data Management, vendors, process owners, and others to analyze risks and issues using quality performance data, identify follow-up actions, and oversee completion of identified actions
  • Draft, maintain, and archive documentation of risk management activities, such as risk/issue(s), controls, findings, escalations, tracking, and resolution, using RBQM tools and following BeiGene SOPs
  • Trend risks and issues across related entities
  • Support the study team and other contributors to clinical development in optimizing controls applied based on risk evaluation, such as optimizing the application of source data verification and source document review
  • Support the study team in optimizing the RBQM model, including acting as a change champion and subject matter expert for a risk-based environment
  • Develop and lead culture change and communication activities with stakeholders
  • Conduct ad-hoc risk assessments as needed to support clinical development

Requirements:

  • 8+ years leading risk assessments in the pharmaceutical industry or equivalent
  • Prior experience deploying risk-based quality management programs across clinical development preferred
  • Ability to work independently to complete management and oversight activities
  • Experience working and communicating within cross-functional teams
  • Knowledge of overall clinical trial management process, understanding of the protocol and other clinical trial-related plans and documents
  • Critical thinking and analytical skills to understand and analyze complex data and provide insight into risk reports, trends, and outliers in data
  • Therapeutic area-specific experience and knowledge – Oncology/Hematology preferred
  • Ability to use relevant technology and risk-based tools/platforms effectively
  • Proven track record in delivering agreed results against a plan and timeline
  • Understanding of ICH and regulatory environment
  • Problem-solving skills
  • Self-management skills
  • Ability to work in a global team environment

Education: Bachelor's or Master's degree in a Business or Science-related field



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