Clinical Insights Analyst I

Job not on LinkedIn

🔥 2 hours ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧐 Business Analyst

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Support cross-functional study teams and RBQM Leads in Protocol Risk Assessment, risk identification, and evaluation into Risk MAP • Support selection and implementation of Key Risk Indicators (KRIs), Quality Tolerance Limit parameters (QTLs), assessments, and dashboards • Conduct end-of-trial summarization of risk management activities for inclusion in the Clinical Study Report • Draft and oversee RBQM system setup specifications • Execute and review study assessments and analyses, diagnosing and explaining data anomalies and risks • Raise signals, issues, and actions in RBQM systems • Deliver timely, high-quality analytics and support RBQM Leads in communicating resolutions to cross-functional study teams • Collaborate with programmers to implement study-specific KRIs, QTLs, visualizations, and analytics in the RBQM system • Perform QC of study setup against RBQM system specifications when required • Act as RBQM programmer for setup of KRIs, QTLs, data quality assessments, and visualizations when required • Maintain the RBQM system based on RBQM Plan requirements, data sources, and structure • Produce and maintain appropriate status and process documentation during the study • Communicate or escalate serious risks and issues to RBQM Leads, study teams, management, and Quality as needed • Ensure inspection readiness for clinical risk management and centralized monitoring activities

🎯 Requirements

• Proven experience in a clinical research environment, with experience in a pharmaceutical/biologics/biotechnology company • Working knowledge of clinical development processes, including study design, conduct and close out, and clinical program development • Knowledge of clinical trial risk management concepts and principles in the Pharma or CRO industry • Experience with data analytics and data visualization technologies • Strong critical thinking and analytical skills, including mathematical and statistical concepts • High degree of accuracy and attention to detail • Experience and understanding of clinical trial data from various sources, including Clinical devices, SDTM, RAVE, and IRT • Ability to work collaboratively in a team environment while managing changing priorities to achieve goals/targets • Excellent English oral and written communication skills