Clinical Risk Manager I

Location: Argentina

Employment type: Full time

Company

hirify.global helps biotech, medtech, and specialty pharmaceutical companies develop medicines, medical devices, and diagnostics.

What you will do

• Develop monitoring strategies based on initial and ongoing clinical trial risk assessments.
• Complete Risk Assessment and Categorization Tool assessments for complex and global trials, identifying critical data, critical processes, protocol execution risks, and mitigations.
• Evaluate and establish Quality Tolerance Limits and confirm that custom monitoring strategies are fit for purpose and risk proportionate.
• Prepare configuration notes for Clinical Analytics and ensure central monitors have the tools required for aggregated data reviews.
• Author Integrated Quality Risk Management Plans and support functional project plans for assigned studies.
• Maintain inspection readiness, support cross-functional risk reviews, and share RBQM process learnings.

Requirements

• Bachelor’s degree in Biological Sciences, Health Sciences, or a related healthcare discipline.
• 8+ years of relevant clinical research experience in risk-based quality management, central 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.
• Experience with Microsoft Excel, business intelligence tools, and data visualizations.
• Excellent verbal and written English communication skills. Ability to travel up to 20% for sponsor meetings.

Culture & Benefits

• Flexibility and balance to support personal and professional needs.
• Opportunities to build skills and grow professionally.
• Collaboration with global cross-functional teams working on medical innovation.
• Opportunity to influence working practices and contribute ideas.