Biometrics Subject Matter Expert (SME) – GCP Internal Audit jobs in United States
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ECI · 7 hours ago

Biometrics Subject Matter Expert (SME) – GCP Internal Audit

positionUnited States
timeContract
remoteRemote
seniorityMid Level

ECI is a global leader in professional consulting services for the life sciences industry, seeking a Biometrics Subject Matter Expert (SME) to support Good Clinical Practice (GCP) internal audits. The role involves providing technical expertise in clinical data management, statistical programming, and biostatistics, partnering with a GCP Auditor to ensure compliance and data integrity.

BiotechnologyConsultingLife ScienceProject Management
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Growth OpportunitiesbadNo H1Bnote

Responsibilities

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

Qualification

GCP knowledgeClinical data managementStatistical programmingBiometrics experienceAudit support experience

Required

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

Preferred

Prior audit or inspection support experience

Company

ECI

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ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
dateFounded in 2012
location
Las Vegas, Nevada, USA
people-size51-200 employees
web-link
https://eci-rx.com

Funding

Current Stage
Growth Stage

Leadership Team

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Michael Boyer
Chief Financial Officer
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Shital Patel
Chief Operating Officer
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Company data provided by crunchbase