Clinical Insights Analyst I

This is a fully remote position, open to applicants in Poland.

📋 Description

• Assist cross-functional study teams and RBQM Leads in conducting Protocol Risk Assessments, identifying risks, and evaluating them within the Risk MAP framework.

• Aid in the selection and implementation of Key Risk Indicators (KRIs), Quality Tolerance Limit parameters (QTLs), assessments, and dashboards.

• Execute end-of-trial summarization of risk management activities for inclusion in the Clinical Study Report.

• Draft and supervise the specifications for RBQM system setup.

• Carry out and review study assessments and analyses, diagnosing and clarifying data anomalies and associated risks.

• Initiate signals, issues, and actions within RBQM systems.

• Provide timely, high-quality analytics and assist RBQM Leads in conveying resolutions to cross-functional study teams.

• Collaborate with programmers to implement study-specific KRIs, QTLs, visualizations, and analytics within the RBQM system.

• Conduct quality control of study setup against RBQM system specifications as necessary.

• Function as the RBQM programmer for the configuration of KRIs, QTLs, data quality assessments, and visualizations when required.

• Maintain the RBQM system in accordance with RBQM Plan requirements, data sources, and structural elements.

• Generate and preserve relevant status and process documentation throughout the study.

• Communicate or escalate significant risks and issues to RBQM Leads, study teams, management, and Quality as necessary.

• Ensure readiness for inspections regarding clinical risk management and centralized monitoring activities.

⛳️ Requirements

• Demonstrated experience in a clinical research setting, preferably within a pharmaceutical, biologics, or biotechnology company.

• Familiarity with clinical development processes, including study design, execution, closeout, and clinical program development.

• Understanding of clinical trial risk management principles and concepts within the Pharma or CRO industry.

• Proficient in data analytics and data visualization technologies.

• Strong analytical and critical thinking abilities, encompassing mathematical and statistical concepts.

• High level of accuracy and attention to detail.

• Experience and insight into clinical trial data from diverse sources, including Clinical devices, SDTM, RAVE, and IRT.

• Capacity to collaborate effectively in a team environment while managing shifting priorities to meet goals and targets.

• Exceptional English verbal and written communication skills.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working hours and the possibility of remote work options.