Risk Manager

Risk Manager

The 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.

Responsibilities:

More specifically, the Risk Manager must:

• 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.
• Coordinate with central monitor team and verify work.
• Provide budget recommendations, change orders.
• 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.
• Escalate risks or deliverables at risk to the PM, including scope changes.
• Provide strategic input on risk characterization and reporting to leadership.
• Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks.

Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements:

• Bachelor's degree in a field relevant to clinical research;
• Minimum of 3 years in risk management within a clinical research setting.
• Minimum 5 years of experience across clinical monitoring, data management, drug safety.
• 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.
• Training, mentoring, and organizational capabilities.
• High level of autonomy.
• Fluent in English (excellent oral and written).
• Must be able to communicate clearly and effectively at all levels within the organization and with external customers.
• Must be a fast learner and able to understand new concepts quickly.
• Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands.
• Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring.
• Broad working knowledge of the roles, functions and process of conducting clinical trials.
• Must be able to manage time effectively, working with multiple functions and requirements.
• Must have been involved in the use of trial management or data management systems.

Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.