Risk Surveillance Lead

This is a fully remote position, open to applicants in United Kingdom, +2 more countries.

📋 Description

• Oversee the risk assessment of trial protocols across various cross-functional areas related to critical data and processes, which includes establishing quality tolerance limits, assessing risks, and ensuring that mitigation strategies and plans are in place.

• Create, maintain, and archive documentation related to risk management specific to each study.

• Collaborate with the RBQM system configuration team to guarantee that risk indicators, quality tolerance limits, and analytics/visualizations are correctly programmed and meet operational requirements.

• Perform periodic central surveillance of aggregated data at both study and program levels to detect any emerging risks or issues.

• Lead risk review meetings and discussions with study and program team members to share findings and assist in identifying root causes and mitigation strategies.

• Assist in and participate in both internal and external audits and inspections.

• Work with training departments to support training initiatives and the adoption of the RBQM approach.

• Promote the implementation of RBQM practices at the trial level, ensuring continuous improvement and oversight.

• Maintain overall responsibility for monitoring quality risks across assigned trials and programs within a matrix structure.

⛳️ Requirements

• Candidates must be located in the UK, Spain, or Ireland (remote work).

• A Bachelor’s Degree in a health-related or life science field, or an equivalent combination of education, training, and experience.

• At least 6 years of experience in the pharmaceutical or CRO industry.

• A minimum of 2 years of experience in Risk Based Quality Management.

• Strong understanding of the drug development process and execution of clinical trials.

• Familiarity with regulatory industry standards such as 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

• Experience with risk management, sponsor audits, health authority inspections, root cause analysis, mitigation strategies, and Corrective Actions Preventive Actions.

• Knowledge of RBQM IT systems or other data analytic systems.

• Proven ability to analyze data, recognize patterns, and recommend improvements.

• Demonstrated capability to effectively lead cross-functional team meetings.

• Experience in building cross-functional collaborations and possessing strong interpersonal skills.

• Employment with ICON is contingent upon possessing the legal right to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs that may include medical, dental, and vision coverage.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.