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 the risk-based monitoring strategy tailored to project needs.
• Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications.
• Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT).
• Guide Project Managers (PMs) in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews.
• Advise on developing functional plans to mitigate risks effectively.
• Utilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity.
• Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations.
• Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies.
• Mentor peers and train new team members on functional delivery, risk evaluation, and action implementation.
• Escalate risks or deliverables at risk to the PM, including scope changes.

Requirements

• Bachelor’s degree in a field relevant to clinical research; master’s degree or health data sciences degree preferred.
• Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements.
• Proficiency in Risk-Based Monitoring strategies, processes, and tools.
• Mastery of MS Excel (sorting, filtering, pivot tables).
• Advanced skills in analytical data visualization tools.
• Knowledge of Lean Six Sigma and web based RACT tools.
• Strong analytical and statistical understanding.
• Excellent communication, negotiation, and leadership skills.
• Ability to anticipate critical issues and develop proactive contingency plans.
• Skilled in project workflows and cross-functional collaboration.

Benefits

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