Clinical Insights Analyst I

About

Description

Cytel is seeking a Clinical Insights Analyst II to assist Risk-Based Quality Management Leads in clinical trials, managing protocol risks, monitoring data integrity, and ensuring safety. The role requires 3 years of pharmaceutical industry experience and strong analytical skills.

Responsibilities

• Support CRA team members in managing protocol, critical data, ‘Critical to Quality’ elements, safety, data integrity, and protocol execution risks
• Assist in Protocol Risk Assessment and risk identification for Risk MAP with RBQM Leads and cross-functional teams
• Help select and implement Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) in the RBQM system
• Set up and maintain the RBQM system; conduct peer reviews, QC, and validation as needed
• Collaborate with programmers to implement and refine study-specific KRIs and QTLs
• Execute and review study assessments, diagnose data anomalies, and address risks
• Provide high-quality risk-based monitoring analytics and assist in communication with cross-functional teams and CROs
• Support RBQM Leads in risk reviews throughout clinical trials and ensure documentation and validation are maintained

Qualifications

• Proven experience in a clinical research environment
• At least 3 years experience in a in a pharmaceutical/biologics/biotechnology company
• Working knowledge of clinical development processes, understanding concepts and principles of study design, conduct and close out, as well as clinical program develop

Application instructions:

• To apply click on the apply button