Senior Risk Manager - Remote

Overview

The Senior Risk Manager plays a pivotal role in developing and executing risk-based monitoring strategies, ensuring data quality and integrity in clinical research projects. This position involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, supporting the seamless implementation of Risk-Based Study Management (RBSM) principles.

In Short

• Provide subject matter expertise for developing and updating risk-based monitoring strategy.
• Collaborate with teams to identify and mitigate risks.
• Draft initial risk assessments and support finalization of tools.
• Guide Project Managers in risk tracking.
• Advise on functional plans for risk mitigation.
• Conduct remote data reviews and identify risks.
• Facilitate internal and sponsor reviews.
• Deliver training for study teams on risk assessment.
• Mentor peers and train new team members.
• Provide strategic input on risk characterization.

Requirements

• Bachelor’s degree in a relevant field; Master’s preferred.
• Expertise in Good Clinical Practice/ICH E6 Guidelines.
• Proficiency in Risk-Based Monitoring strategies.
• Mastery of MS Excel and analytical tools.
• Strong analytical and statistical understanding.
• Excellent communication and leadership skills.
• Minimum of 5 years in risk management in clinical research.
• Fluent in English.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Company benefits package.
• Ongoing learning and development.