Global Clinical RBQM Risk Manager

Orion Pharma; Boston (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Orion Pharma in Boston, MA is seeking a Clinical Risk Manager to lead RBQM across global studies. You will manage central monitoring, provide expert risk management guidance, and collaborate with cross-functional teams to ensure quality and patient safety.

The role emphasizes RBQM implementation, data analysis, and continuous process improvement, with opportunities to influence study design and monitoring strategies within a Nordic-origin company expanding in the U.S.

Qualifications

• Minimum bachelor’s degree and significant relevant biotechnology/pharmaceutical industry experience or equivalent.
• Strong direct RBQM systems experience

Responsibilities

• Lead RBQM-related study start-up processes (protocol de-risking, risk assessment, monitoring strategy input).
• Develop and author Clinical Trial Risk Management Plan.
• Act as SME for RBQM configuration, implementation, and execution across studies.
• Provide leadership, training, and escalation for Central Monitoring RBQM issues.
• Conduct and communicate study-level central monitoring reviews using data analysis tools.
• Interpret KRIs and related data to assess trends and issues.
• Support teams in understanding root causes and follow-up actions.
• Document outputs from Central Monitoring reviews and track actions to closure.
• Contribute to ongoing development of RBQM models and processes.
• Participate in standardizing RBQM systems, documentation, and training materials.

Skills

RBQM systems

Central monitoring

Data analysis

ICH/GCP knowledge

Regulatory compliance

Clinical trial operations

Leadership in cross-functional teams

Communication

Education

Bachelor's degree

Job description

Orion Pharma in Boston, MA is seeking a Clinical Risk Manager to lead RBQM across global studies. You will manage central monitoring, provide expert risk management guidance, and collaborate with cross-functional teams to ensure quality and patient safety.

The role emphasizes RBQM implementation, data analysis, and continuous process improvement, with opportunities to influence study design and monitoring strategies within a Nordic-origin company expanding in the U.S.