Clinical IT Quality Control Analyst

📋 Description

• Provide quality and compliance guidance to research operations and IT teams regarding software
• Oversee quality activities related to software, processes, and data-integrity validation within
• Review validation lifecycle documentation, including validation assessments, 21 CFR Part 11
• Ensure validation documentation is complete, accurate, and aligned with established SOPs, corporate
• Support quality activities throughout the preparation, execution, data analysis, and reporting
• Conduct or support periodic reviews of system documentation to confirm ongoing compliance with

🎯 Requirements

• Bachelor’s degree required; equivalent professional experience may be considered in place of formal
• Direct professional experience in a quality assurance or quality control role involving
• At least 3 years of professional experience in clinical research, biotechnology, pharmaceutical, or
• Strong experience working with FDA GxP requirements for computerized systems, 21 CFR Part 11, and
• Experience within a GCP clinical research environment, such as a CRO or SMO, is highly preferred.
• Knowledge of software quality and validation standards such as GAMP V, PIC/S, ICH, and related

🎁 Benefits

• Fully remote position within the United States.
• Comprehensive benefits designed to support physical, mental, and financial well-being.
• Competitive compensation based on factors including experience, skills, performance, equity
• Potential eligibility for additional compensation such as annual bonus or long-term incentive
• Opportunities to work within a clinical research environment focused on advancing oncology
• Collaborative exposure to IT quality, computerized systems validation, clinical research, and