Biometrics Subject Matter Expert (SME) – GCP Internal Audit #8352
About ECI ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry. About the role The Biometrics Subject Matter Expert (SME) supports Good Clinical Practice (GCP) internal audits by providing technical expertise across clinical data management, statistical programming, and biostatistics. This role partners with a GCP Auditor to assess biometrics-related processes, systems, and deliverables for regulatory compliance, data integrity, and inspection readiness. What you'll do • Review EDC/ADC system setup, configuration, and validation • Assess query management, data cleaning, and issue resolution processes • Evaluate vendor oversight and CRO management • Verify compliance with GCP, SOPs, and internal quality standards • Assess data integrity controls throughout the data lifecycle • Review validation of analysis datasets • Evaluate QC processes for statistical programs • Assess traceability from raw data to Tables, Figures, and Listings (TFLs) • Confirm adherence to programming standards and documentation • Assess staff adherence to statistical processes and plans • Review accuracy and consistency of statistical outputs • Evaluate controls supporting statistical integrity and reproducibility • Participate in audit planning, walkthroughs, and interviews • Review study documentation and validation records • Identify risks, gaps, and compliance issues • Support audit observations and reporting What you will bring • Experience in biometrics within clinical research or pharmaceutical industry • Strong knowledge of GCP and regulatory expectations • Hands-on experience with clinical data management systems • Experience reviewing statistical programming deliverables • Prior audit or inspection support experience preferred ECI is an equal opportunity employer. All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity. Apply tot his job