Clinical Trial Risk Manager

1 week ago

Dublin, Dublin City, Ireland beBeeRisk Full time €95,000 - €110,000
Job Title:Risk Surveillance Lead

The Risk-Based Quality Management (RBQM) Risk Surveillance Lead plays a pivotal role in driving the adoption of RBQM practices at the trial level and overseeing their implementation and continuous improvement.

This position operates within a matrix environment and holds overall accountability for monitoring quality risks across assigned trials and programs, enabling comprehensive clinical quality (GCP) risk governance.

The role demonstrates leadership in influencing and enhancing clinical trial quality through expert understanding of protocols, processes, regulatory requirements, and quality management principles.

The Risk Surveillance Lead facilitates critical thinking and problem-solving to identify and mitigate potential risks, ensuring compliance with regulatory standards including 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

Key Responsibilities:

  • Conduct Comprehensive Risk Assessments: Conduct thorough assessments across multiple cross-functional domains related to critical-to-quality (CtQ) data and processes, defining quality tolerance limits (QTLs) and evaluating risks based on likelihood, detectability, and impact.
  • Maintain Accurate Documentation: Draft, maintain, and archive study-specific documentation of risk management activities, such as the Integrated Quality Risk Management Plan (IQRMP).
  • Collaborate with RBQM Configuration Team: Partner with the RBQM system configuration team to ensure risk indicators, quality tolerance limits, and analytics/visualizations are programmed and functioning according to operational requirements in the RBQM system.
  • Conduct Centralized Surveillance: Periodically review aggregate data at the study and program levels, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks or issues.
  • Foster Effective Communication: Coordinate risk review meetings with study and program team members to communicate findings, support root cause analysis, and develop mitigation strategies.
  • Promote Compliance: Participate in internal and external audits and inspections, ensuring adherence to regulatory standards and RBQM best practices.
  • Cultivate Knowledge Sharing: Support training initiatives and promote RBQM adoption, fostering a culture of continuous improvement and knowledge sharing.

Please note that this job description has been modified to better reflect the original content. The final output size does not exceed 7000 tokens.

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