Risk Manager – Clinical Research

Innovaderm Research Inc.

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

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

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Risk-Based Monitoring strategies and processes, with a strong foundation in Good Clinical Practice/ICH E6 (R3) Guidelines. Capable of collaborating across functions to identify and mitigate risks in clinical research settings while providing training and strategic input to project teams.

Highest-signal resume keywords

Risk-Based Monitoring StrategiesGood Clinical Practice/ICH E6 (R3) GuidelinesClinical MonitoringData ManagementAnalytical Data Visualization Tools

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementStatistical UnderstandingProject WorkflowsChange OrdersRisk Assessment ToolsMS ExcelLean Six SigmaCentralized MonitoringData QualityTrial Management Systems

Soft Skills

Excellent CommunicationNegotiation SkillsLeadership SkillsOrganizational CapabilitiesPrioritization Skills

Tools & Technologies

Web-Based RACT ToolsAnalytical Data Visualization ToolsCentralized Statistical Monitoring

Industry Keywords

Clinical ResearchCROPharma IndustryHealth Canada RegulationsFDA RegulationsDermatology TrialsRheumatology Trials

About the role

Key responsibilities & impact

Develop and update risk-based monitoring strategies tailored to project needs
Provide subject matter expertise for risk-based monitoring strategy development
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 developing functional plans to mitigate risks
Use tools to conduct remote data reviews and centralized statistical monitoring, identifying 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 or at-risk deliverables, including scope changes, to the Project Manager
Provide strategic input on risk characterization and reporting to leadership
Undertake additional responsibilities aligned with qualifications and training
Collaborate with colleagues across a global clinical research organization supporting dermatology and rheumatology trials

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 of 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 skills
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 project documentation, including centralized monitoring and risk-based monitoring
Broad working knowledge of the roles, functions, and processes involved in conducting clinical trials
Ability to manage time effectively while working with multiple functions and requirements
Involvement in 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
Must be legally able to work in Romania

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request