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Clinical Outcomes Solutions is a global consultancy focused on clinical outcome assessment (COA) research for pharmaceutical and biotechnology organizations. Its team develops research strategies and practical solutions for capturing reliable data about patients’ experiences, helping clients address the scientific and regulatory complexities of clinical outcomes work. By bringing the patient voice into research design and evidence generation, the company supports informed care decisions and stronger patient outcomes.
Clinical Insights Analyst I – Poland Remote
Support pharmaceutical clients with clinical trial risk analytics and risk-based quality management systems. Build risk indicators, dashboards, data assessments, and inspection-readiness documentation.
Description
- Support cross-functional study teams and RBQM Leads with protocol risk assessments, risk identification, and Risk MAP evaluation
- Help select and implement Key Risk Indicators, Quality Tolerance Limits, assessments, and dashboards
- Summarize end-of-trial risk management activities for inclusion in Clinical Study Reports
- Draft and oversee RBQM system setup specifications
- Perform and review study assessments and analyses, identifying and explaining data anomalies and risks
- Record signals, issues, and actions in RBQM systems
- Provide timely, accurate analytics and help RBQM Leads communicate resolutions to cross-functional study teams
- Work with programmers to implement study-specific KRIs, QTLs, visualizations, and analytics in RBQM systems
- Conduct quality control reviews of study setups against RBQM specifications when needed
- Serve as an RBQM programmer for KRI, QTL, data quality assessment, and visualization setup when required
- Maintain RBQM systems in line with RBQM Plans, data sources, and structural requirements
- Create and maintain study status records and process documentation
- Communicate or escalate significant risks and issues to RBQM Leads, study teams, management, and Quality as appropriate
- Maintain inspection readiness for clinical risk management and centralized monitoring activities
Requirements
- Demonstrated clinical research experience in a pharmaceutical, biologics, or biotechnology organization
- Working knowledge of clinical development processes, including study design, execution, closeout, and clinical program development
- Understanding of clinical trial risk management principles in the pharmaceutical or CRO sector
- Experience using data analytics and visualization technologies
- Strong critical-thinking and analytical abilities, including mathematical and statistical reasoning
- Exceptional accuracy and attention to detail
- Experience interpreting clinical trial data from sources such as clinical devices, SDTM, RAVE, and IRT
- Ability to collaborate effectively while adapting to shifting priorities and delivery targets
- Excellent spoken and written English communication skills
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