Risk Manager – Clinical Research
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Job Description
Risk Manager developing risk-based monitoring strategies for Indero, a dermatology and rheumatology clinical research CRO. Supporting data integrity, regulatory compliance, and cross-functional trial delivery.
Responsibilities:
- Develop and update risk-based monitoring strategies tailored to project needs
- Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications
- Coordinate with the central monitor team and verify work when required
- Provide budget recommendations and change orders
- Draft initial risk assessments and support finalization of Risk Assessment and Categorization Tools (RACT)
- Guide Project Managers in transferring identified risks to appropriate tracking systems and ensure ongoing reviews
- Advise on functional plans to mitigate risks effectively
- Use tools for remote data reviews and centralized statistical monitoring to identify risks to data quality and integrity
- Facilitate internal and sponsor reviews of findings and obtain cross-functional support for complex risks and mitigations
- Deliver initial and ongoing training to study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies
- Escalate risks or at-risk deliverables, including scope changes, to the Project Manager
- Provide strategic input on risk characterization and reporting to leadership
- Assume additional responsibilities as required when appropriately qualified and trained
Requirements:
- Bachelor’s degree in a field relevant to clinical research
- 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)
- Ability to communicate clearly and effectively at all levels within the organization and with external customers
- Fast learner 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 and project documentation, including centralized monitoring and risk-based monitoring
- Broad working knowledge of the roles, functions and process of conducting clinical trials
- Ability to manage time effectively while working with multiple functions and requirements
- Involvement 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
- Must be legally able to work in Bulgaria
Benefits:
- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Stimulating work environment
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