Risk Surveillance Lead

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Lead the assessment of trial protocol risks across various cross-functional areas (clinical, operational, data management, vendors, regulatory, etc.) related to critical-to-quality (CtQ) data and processes, encompassing the establishment of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, and impact, while ensuring that mitigation strategies and plans are clearly defined.

• Accountable for the creation, maintenance, and archiving of study-specific documentation concerning risk management activities.

• Collaborate with the RBQM system configuration team to confirm that risk indicators, quality tolerance limits, and other analytics/visualizations are programmed and operate according to operational specifications within the RBQM system.

• Conduct regular central surveillance of aggregate data at both the study and program levels, utilizing available analytics/visualizations in the RBQM system to pinpoint emerging risks and/or issues.

• Organize risk review meetings and discussions with study/program team members to effectively relay and discuss findings, while supporting robust root cause identification and mitigation strategies.

• Participate in and support internal and external audits and inspections.

• Work in conjunction with training departments to facilitate training initiatives and promote the adoption of the RBQM approach.

⛳️ Requirements

• Bachelor’s Degree in a health-related or life science discipline, or a comparable combination of education, training, and professional 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 clinical trial execution.

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

• Experience in risk management, sponsor audits, health authority inspections, root cause analyses, and mitigation strategies, as well as Corrective Actions Preventive Actions.

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

• Proven ability to analyze data, recognize patterns, and make improvement recommendations.

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

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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