Risk Surveillance Lead

4 weeks ago

Dublin, Dublin City, Ireland Healthcare Businesswomen's Association Full time
Job Description Summary

The Risk-Based Quality Management (RBQM) Risk Surveillance Lead is responsible for driving the adoption of RBQM practices at the trial level and overseeing their implementation and continuous improvement. The Risk Surveillance Lead works 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.

This role can be based in our offices in Dublin, Ireland, or Barcelona, Spain, with an expectation of three days on-site per week.

Major Accountabilities:

1. Facilitate trial protocol risk assessments across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory, etc.) related to critical-to-quality (CtQ) data and processes, including defining quality tolerance limits (QTLs), evaluating risks based on likelihood, detectability, impact, and ensuring mitigation strategies are defined.

2. Draft, maintain, and archive study-specific documentation of risk management activities, such as the Integrated Quality Risk Management Plan (IQRMP).

3. 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.

4. Conduct periodic central surveillance of aggregate data at the study and program levels, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks or issues.

5. Facilitate risk review meetings with study and program team members to communicate findings, support root cause analysis, and develop mitigation strategies.

6. Support and participate in internal and external audits and inspections.

7. Collaborate with training departments to support training initiatives and promote RBQM adoption.

8. Share lessons learned, best practices, successes, failures, and opportunities for process improvement to foster continuous improvement and consistency in RBQM processes.

9. Act as a change agent, champion, and subject matter expert in RBQM methodology, guiding study teams to adhere to best practices for maximum benefit.

Experience:

- Bachelor's Degree in a health-related or life sciences field, or equivalent 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 drug development and clinical trial execution.

- Knowledge of regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP).

- Experience with risk management, sponsor audits, health authority inspections, root cause analysis, and CAPA.

- Knowledge of RBQM IT systems or similar data analytics tools.

- Ability to analyze data, identify patterns, and recommend improvements.

- Effective leadership in cross-functional team meetings.

- Strong interpersonal skills for collaboration.

- Supportive of continuous improvement and knowledge sharing culture.

- Ability to influence without authority.

- Creative thinking and challenge of the status quo.

Languages:

English: fluent in written and spoken.

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