Clinical Risk Manager I

Location: Serbia

Company

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

What you will do

• Develop monitoring strategy rationales for clinical bids, proposals, and business development activities.
• Complete study risk 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 monitoring strategies are fit for purpose and risk proportionate.
• Author Integrated Quality Risk Management Plans and support functional project plans throughout the project lifecycle.
• Provide subject matter expertise in Risk-Based Quality Management and Risk-Based Monitoring, including centralized monitoring and clinical analytics.
• Maintain inspection-ready documentation, support kickoff meetings, and share RBQM process learnings.

Requirements

• Bachelor's degree in Biological Sciences, Health Sciences, or a related healthcare discipline.
• 8+ years of relevant experience in RBQM, central monitoring, clinical research, 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 MS Excel, Business Intelligence tools, and data visualizations for decision-making.
• Excellent written and verbal English communication skills; ability to travel up to 20% for sponsor meetings.

Culture & Benefits

• Professional growth through skills development and opportunities to excel.
• Flexible working practices intended to support work-life balance.
• Opportunity to contribute to clinical research and medical innovation.
• Collaboration with cross-functional global teams.