Risk Manager, Clinical Research

Innovaderm Research Inc.

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

Posted 11/6/2026full-timeRemote • PolandMid-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 effective cross-functional collaboration and communication, ensuring risk management and data integrity in clinical research settings.

Highest-signal resume keywords

Risk-Based Monitoring StrategiesGood Clinical Practice/ICH E6 (R3) GuidelinesClinical Research ExperienceAnalytical Data Visualization ToolsProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementData ManagementStatistical AnalysisMS Excel ProficiencyLean Six Sigma KnowledgeCentralized MonitoringRisk Assessment ToolsClinical Trial ProtocolsRegulatory ComplianceTrial Management Systems

Soft Skills

Excellent CommunicationLeadership SkillsNegotiation SkillsOrganizational CapabilitiesFast Learner

Tools & Technologies

Web-Based RACT ToolsAnalytical Data Visualization ToolsCentralized Monitoring 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 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 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
Assume additional responsibilities aligned with qualifications, experience, and training

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 documentation, including centralized monitoring and risk-based monitoring
Broad working knowledge of clinical trial roles, functions, and processes
Ability to manage time effectively across 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 authorized to work in Poland

Benefits

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Equal opportunity and accommodations throughout the recruitment and selection process, upon request