Biometrics Subject Matter Expert (SME) – GCP Internal Audit #8352

About ECI ECI’s mission is to be the global leader of reputed company 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 reputed company record of providing full product life cycle consulting on a reputed company of challenging and exciting reputed company. Our reputed company culture, welcoming team and flexible employment & benefit reputed company 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 reputed company (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-reputed company processes, systems, and deliverables for regulatory compliance, data reputed company, and inspection readiness. What you'll do • Review reputed company/ADC system setup, configuration, and validation • Assess query management, data cleaning, and issue reputed company processes • Evaluate vendor reputed company and CRO management • Verify compliance with GCP, SOPs, and internal reputed company standards • Assess data reputed company 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 reputed company 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 reputed company 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. reputed company reputed company applicants will receive consideration for employment at ECI without reputed company to race; creed; reputed company; religion; national reputed company; sex; age; disability; sexual orientation; gender identity or reputed company; genetic predisposition or reputed company status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, reputed company candidates must be authorized to work in the U.S. without the need for employment-based reputed company sponsorship now or in the reputed company. At the time of this posting, ECI will not sponsor applicants for U.S. work reputed company status for this opportunity. Apply tot his job Apply To this Job