Risk Manager – Clinical Research

Innovaderm Research Inc.

. Develop and update risk-based monitoring strategies tailored to project needs .

Posted 11/6/2026full-timeRemote • CzechiaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Risk-Based Monitoring strategies and processes within clinical research, with strong analytical skills and proficiency in data management tools. Capable of effective communication and collaboration across cross-functional teams to mitigate risks and ensure data integrity.

Highest-signal resume keywords

Risk-Based Monitoring StrategiesGood Clinical Practice/ICH E6 (R3) GuidelinesData Management SystemsAnalytical Data Visualization ToolsClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementStatistical AnalysisMS Excel MasteryLean Six Sigma KnowledgeRisk Assessment ToolsProject WorkflowsCentralized MonitoringClinical Trial ProtocolsData Quality AssuranceBudget Recommendations

Soft Skills

Excellent CommunicationLeadership SkillsNegotiation SkillsOrganizational CapabilitiesPrioritization Skills

Tools & Technologies

Web-Based RACT ToolsTrial Management SystemsData Management SystemsStatistical Monitoring ToolsAnalytical Tools

Industry Keywords

Clinical Research Organization (CRO)Pharmaceutical IndustryHealth Canada RegulationsFDA RegulationsClinical Trials

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 as needed
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
Conduct remote data reviews and centralized statistical monitoring to identify risks to data quality and integrity
Facilitate internal and sponsor reviews of findings, securing 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
Undertake additional responsibilities aligned with qualifications and training
Work with clinical research teams at Indero, a dermatology and rheumatology clinical research CRO

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, 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
Experience using trial management or data management systems
Good knowledge of good clinical practices and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
Legally authorized to work in Czech Republic

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Equitable treatment and equal opportunity
Recruitment and selection accommodations for applicants with disabilities, upon request