Risk Manager – Clinical Research

Innovaderm Research Inc.

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

Posted 11/8/2026full-timeRemote • BulgariaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Risk-Based Monitoring strategies and tools, with a strong foundation in Good Clinical Practice and regulatory requirements. Capable of effective cross-functional collaboration and communication, ensuring risk mitigation and project success in clinical research settings.

Highest-signal resume keywords

Risk-Based Monitoring StrategiesGood Clinical Practice/ICH E6 (R3) GuidelinesMS Excel MasteryAnalytical Data Visualization ToolsClinical Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk ManagementData ManagementDrug SafetyStatistical UnderstandingProject WorkflowsLean Six SigmaCentralized MonitoringRisk Assessment ToolsContingency PlanningClinical Trial Processes

Soft Skills

Excellent CommunicationNegotiation SkillsLeadership SkillsTraining and MentoringPrioritization Skills

Tools & Technologies

Web Based RACT ToolsTrial Management SystemsData Management SystemsRemote Data Review ToolsStatistical Monitoring Tools

Industry Keywords

CROPharma 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 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

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
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

Comp & perks

Flexible work schedule
Permanent full-time position
Ongoing learning and development
Attractive advancement opportunities
Stimulating work environment