Senior Clinical Data Risk Analyst

Senior Clinical Data Risk Analyst - United States (Remote)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We have an incredible opportunity for a Senior Clinical Data Risk Analyst to join ICON's Full-Service IOD Clinical Risk Management team. The Senior CDRA is a clinical risk management and central monitoring functional lead of multiple moderate complexity studies. The CDRA is responsible for clinical data analysis components of clinical studies, including RBQM facilitation, planning, selection of KRIs focusing on identified risks, advanced analytics design and programming specifications, review of centrally aggregated data to identify risk and issues impacting data integrity, patient safety, and regulatory compliance.

Locations:
United States (Remote)

• Signal tracking, system user support, and communication of trends to internal and external stakeholders
• Conducting QC and oversight activities within the Central Monitoring team
• Leading the evaluation of clinical trial data to identify potential risks and trends that may impact study outcomes
• Collaborating with cross-functional teams to develop and implement risk mitigation strategies that enhance data quality and integrity
• Overseeing the analysis of data discrepancies and inconsistencies, providing insights to inform decision-making processes
• Providing guidance on best practices for data governance and compliance within clinical research
• Establishing partnerships with stakeholders to ensure alignment on risk management processes and data quality standards
• Providing mentoring for junior staff

• 5+ years of experience in clinical data analysis or risk management in a clinical research organization or pharmaceutical company
• Strong analytical skills with proficiency in statistical software and risk assessment methodologies
• Attention to detail and a proactive approach to identifying and addressing data risks
• Knowledge of at least 1 Clinical Data Management System (Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, etc.)
• Ability to manage multiple studies simultaneously while handling changing priorities and competing deadlines
• Excellent written and oral communication skills
• Bachelor's degree or local equivalent (in life sciences or related field preferred)
• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language.

* Please submit all applications in English