Clinical Trial Risk Manager

1 week ago

Dublin, Dublin City, Ireland beBeeRiskManagement Full time €90,000 - €120,000
Senior Risk Management Specialist

This position is responsible for driving the adoption of risk-based quality management practices within clinical trial environments.

The ideal candidate will have a strong understanding of quality management principles and be able to facilitate risk assessments across multiple cross-functional domains.

Additionally, this role requires excellent leadership skills to influence and improve clinical trial quality through expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles.

The Senior Risk Management Specialist will work in a matrix environment with overall accountability for surveillance of quality risks across assigned trials and programs, enabling comprehensive clinical quality risk governance.

This role can be based in various locations, with an expectation of regular collaboration and communication with team members.

Key Responsibilities:
  • Facilitate trial protocol risk assessment across multiple cross-functional domains associated with critical-to-quality data and processes.
  • Responsible for drafting, maintaining, and archiving study-specific documentation of risk management activities.
  • Partner with the RBQM system configuration team to ensure risk indicators and other analytics/visualizations are programmed and functioning per operational requirements.
  • Conduct periodic central surveillance of aggregate data at the study and potentially program level to identify emerging risks and/or issues.
  • Facilitate risk review meetings and discussions with study and potentially program team members to communicate findings and support robust root cause identification and mitigation strategies.
  • Support internal and external audits and inspection.
Required Skills and Qualifications:
  • Bachelor's degree in a health-related or life science area, or equivalent combination of education, training, and work experience.
  • Minimum of 4 years of experience in the pharmaceutical or CRO industry.
  • Preferred minimum of 1 year of experience in Risk-Based Quality Management.
  • Robust understanding of the drug development process and clinical trial execution.
  • Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP).
What We Offer:
  • Opportunity to work with a talented team of professionals.
  • Collaborative and dynamic work environment.
  • Professional growth and development opportunities.

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