Note: The job is a remote job and is open to candidates in USA. Indero is a global clinical leader in dermatology and rheumatology, and they are seeking a Risk Manager (Clinical Research) to develop and execute risk-based monitoring strategies. This role involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, ensuring data quality and integrity in clinical research projects.

Responsibilities

• 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
• May have to coordinate with central monitor team and verify work
• Point sur 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

Skills

• Bachelor's degree in a field relevant to clinical research
• Must have experience in a CRO or pharma industry
• 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

Benefits

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

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