Risk Manager-Canada

The Risk Manager is responsible for developing and executing risk-based monitoring strategies in clinical research projects, ensuring data quality and integrity, and collaborating across functions to mitigate risks throughout the clinical trial lifecycle.

Location: India (home-based)

Responsibilities

• Develop and update risk-based monitoring strategies tailored to project needs.
• Collaborate with cross-functional teams to identify and mitigate risks.
• Coordinate with central monitor team and verify work.
• Provide budget recommendations and change orders.
• Draft initial risk assessments and support finalization of Risk Assessment and Categorization Tools (RACT).
• Guide Project Managers in risk transfer and ongoing reviews.
• Advise on functional plans to mitigate risks.
• Conduct remote data reviews and centralized statistical monitoring.
• Facilitate reviews of findings and seek cross-functional support.
• Deliver training on risk assessment and monitoring strategies.
• Escalate risks or deliverables at risk to the Project Manager.
• Provide strategic input on risk characterization and reporting.
• Perform additional responsibilities as required.

Requirements

• Bachelor’s degree in a field relevant to clinical research.
• Minimum 3 years in risk management within a clinical research setting.
• Minimum 5 years of experience in clinical monitoring, data management, or drug safety.
• Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and regulatory requirements.
• Proficiency in Risk-Based Monitoring strategies, processes, and tools.
• Mastery of MS Excel and advanced data visualization tools.
• Knowledge of Lean Six Sigma and web-based RACT tools.
• Strong analytical and statistical skills.
• Excellent communication, negotiation, and leadership skills.
• Ability to anticipate issues and develop contingency plans.
• Skilled in project workflows and cross-functional collaboration.
• Training, mentoring, and organizational skills.
• High autonomy.
• Fluent in English.
• Effective communication skills at all organizational levels.
• Fast learner with quick understanding of new concepts.
• Prioritization and workload management skills.
• Understanding of clinical trial processes and documentation.
• Experience with trial management or data management systems.
• Knowledge of GCP, Health Canada, FDA regulations.

Benefits

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

Additional Information

• This is a home-based position in India with some meetings outside regular hours.
• The company is Indero, a global leader in dermatology and rheumatology clinical research, with a focus on innovation, collaboration, reliability, and responsiveness.