Note: The job is a remote job and is open to candidates in USA. ICON plc is a healthcare intelligence and clinical research organization. The Senior Clinical Data Risk Analyst leads clinical risk management and central monitoring for multiple moderate-complexity studies, analyzing clinical data to identify risks affecting data integrity, patient safety, and regulatory compliance. The role also supports risk-based quality management, data governance, stakeholder collaboration, and mentoring junior staff.
Responsibilities
- 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
Skills
- 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
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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