Senior RBQM Clinical Risk Lead – Hybrid

Orion Corporation; Cambridge; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

Orion Pharma seeks a Clinical Risk Manager to lead RBQM across global studies, guiding central monitoring and risk management with cross-functional teams. You will drive quality, compliance, and patient safety in Orion's development programs.

The role requires expertise in central monitoring, ICH/GCP familiarity, and strong analytical skills to interpret KRIs and trends across studies.

Qualifications

• Minimum bachelor’s degree with biotechnology/pharma industry experience or equivalent.
• Proven expertise in central monitoring and RBQM implementation.
• Strong analytical and communication skills for cross-functional teams.

Responsibilities

• Lead cross-functional study teams in RBQM-related startup activities and monitoring strategy.
• Develop and author the Clinical Trial Risk Management Plan.
• Act as SME for RBQM system configuration, implementation, and execution.
• Provide leadership and training on RBQM issues within Central Monitoring.
• Conduct and communicate study-level central monitoring reviews using data tools.
• Interpret KRIs/QTLs and trends to guide sponsor actions and study decisions.

Skills

Central Monitoring

RBQM knowledge

Leadership

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in a relevant field

Tools

RBQM systems

Analytical tools

Job description

Orion Pharma seeks a Clinical Risk Manager to lead RBQM across global studies, guiding central monitoring and risk management with cross-functional teams. You will drive quality, compliance, and patient safety in Orion's development programs.

The role requires expertise in central monitoring, ICH/GCP familiarity, and strong analytical skills to interpret KRIs and trends across studies.