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United States
Remote only
Not Available
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical IT Quality Control Analyst based in United States.
This remote role supports the quality, compliance, and validation of technology used in clinical research environments.
You will help ensure software, processes, and data integrity meet rigorous quality and regulatory standards.
The position works across IT, research operations, quality, validation, and business teams to strengthen compliant technology practices.
You will review validation documentation, assess system and process changes, and provide quality guidance throughout the validation lifecycle.
The role offers the opportunity to apply expertise in GxP, computerized systems validation, and regulated clinical environments.
Your work will help maintain reliable, audit-ready systems that support clinical research and ultimately contribute to better patient outcomes.
This is a collaborative opportunity for a detail-oriented quality professional who is comfortable operating within highly regulated environments.
Provide quality and compliance guidance to research operations and IT teams regarding software validation, quality management, GxP requirements, and applicable regulatory standards.
Oversee quality activities related to software, processes, and data-integrity validation within computerized systems.
Review validation lifecycle documentation, including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk-management plans, and validation summary reports.
Ensure validation documentation is complete, accurate, and aligned with established SOPs, corporate policies, quality standards, and regulatory requirements.
Support quality activities throughout the preparation, execution, data analysis, and reporting phases of IQ, OQ, and PQ protocols.
Conduct or support periodic reviews of system documentation to confirm ongoing compliance with applicable procedures, standards, and regulations.
Perform quality reviews of changes that may affect validated systems or processes and help ensure appropriate controls are maintained.
Collaborate closely with IT QC specialists, validation specialists, business and product owners, product analysts, and global quality teams.
Provide additional quality and compliance support as needed to maintain effective clinical technology and validation processes.
Bachelor’s degree required; equivalent professional experience may be considered in place of formal education.
Direct professional experience in a quality assurance or quality control role involving computerized systems validation.
At least 3 years of professional experience in clinical research, biotechnology, pharmaceutical, or a related regulated environment.
Strong experience working with FDA GxP requirements for computerized systems, 21 CFR Part 11, and FDA software validation guidance.
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 industry frameworks.
Understanding of pharmaceutical, biologics, CRO, and clinical-site requirements relating to 21 CFR Part 11 and computerized systems validation.
Familiarity with European regulatory requirements, including EU Annex 11, is preferred.
Strong analytical and documentation skills, with the ability to review complex validation materials for accuracy, completeness, and compliance.
Excellent communication and collaboration skills, with the ability to work effectively across technical, quality, operational, and business teams.
Strong attention to detail and the ability to manage multiple priorities in a regulated, deadline-driven environment.
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 considerations, market conditions, and geographic location.
Potential eligibility for additional compensation such as annual bonus or long-term incentive opportunities.
Opportunities to work within a clinical research environment focused on advancing oncology treatments and improving patient outcomes.
Collaborative exposure to IT quality, computerized systems validation, clinical research, and regulatory compliance.
Professional development opportunities and resources designed to support career growth.
Inclusive work environment with an emphasis on diversity, collaboration, and employee well-being.
No relocation assistance or visa sponsorship is available for this position.
