Clinical Risk Manager I

Location: United Kingdom

Company

hirify.global supports biotech, medtech, and specialty pharma companies in developing medicines, medical devices, and diagnostics.

What you will do

• Develop monitoring strategies based on initial risk assessments for clinical bids, proposals, and awarded studies.
• Complete study Risk Assessment Categorization Tools (RACT) for complex and global trials, identifying critical data, critical processes, protocol execution risks, and mitigations.
• Evaluate Quality Tolerance Limits (QTLs), lead parameter-setting discussions, and confirm that monitoring strategies are fit for purpose and risk proportionate.
• Support Central Monitors with tools for aggregated data reviews and create configuration notes for Clinical Analytics programmers.
• Author Integrated Quality Risk Management Plans and support functional project plans and ongoing cross-functional risk reviews.
• Maintain inspection readiness documentation, support kick-off meetings, and share RBQM process knowledge across the team.

Requirements

• Bachelor’s degree in biological sciences, health sciences, or a related healthcare discipline.
• 8+ years of relevant clinical research experience in RBQM, centralized monitoring, and project management.
• Expertise in RBQM, Key Risk Indicators, Quality Tolerance Limits, Quality by Design, centralized monitoring, budgeting, and contracts.
• Strong understanding of statistical concepts, statistical analysis techniques, and integrated quality risk management theories.
• Experience with Microsoft Excel, business intelligence tools, and data visualizations for decision-making.
• Excellent verbal and written English communication skills; ability to travel up to 20% for sponsor meetings.

Nice to have

• Subject matter expertise in ICH-GCP, ICH E6 (R2 and R3) guidelines, and RACT tools.

Culture & Benefits

• Development opportunities and support for building skills and advancing professionally.
• Flexibility and work-life balance support.
• Opportunity to influence working practices and contribute to medical innovation.
• Collaboration with cross-functional global teams on complex clinical research programs.