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Risk Manager – Clinical Research
Innovaderm Research Inc.. Develop and update risk-based monitoring strategies tailored to project needs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Risk-Based Monitoring strategies and processes, with a strong foundation in Good Clinical Practice/ICH E6 (R3) Guidelines. Capable of effective cross-functional collaboration and communication, ensuring data quality and integrity throughout clinical research projects.
Highest-signal resume keywords
Risk-Based Monitoring StrategiesGood Clinical Practice/ICH E6 (R3) GuidelinesClinical MonitoringData ManagementAnalytical Data Visualization Tools
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Risk ManagementData Quality AssessmentStatistical AnalysisProject WorkflowsBudget RecommendationsChange OrdersRisk Assessment ToolsCentralized MonitoringTrial Management SystemsLean Six Sigma
Soft Skills
Excellent CommunicationLeadership SkillsNegotiation SkillsTraining and MentoringTime Management
Tools & Technologies
MS ExcelWeb-Based RACT ToolsAnalytical Data Visualization Tools
Industry Keywords
Clinical ResearchCROPharma IndustryHealth Canada RegulationsFDA Regulations
About the role
Key responsibilities & impact- 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
- Conduct remote data reviews and centralized statistical monitoring using available tools
- Identify risks to data quality and integrity
- Facilitate internal and sponsor reviews of findings
- Seek 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, at-risk deliverables, and scope changes to the Project Manager
- Provide strategic input on risk characterization and reporting to leadership
- Perform additional responsibilities as assigned when qualified and adequately trained
Requirements
What you’ll need- 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, and 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, including sorting, filtering, and 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, with excellent oral and written communication
- Ability to communicate clearly and effectively at all organizational levels and with external customers
- Fast learner able to understand new concepts quickly
- Prioritization skills and ability to plan, monitor, and manage workload in response to changing project demands
- Excellent understanding of project protocols and documentation, including centralized monitoring and risk-based monitoring
- Broad working knowledge of clinical trial roles, functions, and processes
- Effective time management while working with multiple functions and requirements
- Experience using trial management or data management systems
- Good knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines
- Must be legally able to work in the Philippines
Benefits
Comp & perks- Flexible work schedule
- Permanent full-time position
- Ongoing learning and development
- Attractive advancement opportunities
- Recruitment and selection accommodations for applicants with disabilities, upon request