Clinical IT Quality Control Analyst - Remote US

Summary

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is a leading oncology research organization conducting community-based clinical trials and advancing cancer treatments. The Clinical IT Quality Control Analyst oversees software, process, and data integrity validation activities while supporting compliance with GxP, 21 CFR Part 11, and regulatory requirements. The role reviews validation documentation, guides IQ/OQ/PQ protocol activities, and supports ongoing quality oversight of validated systems and processes.

Responsibilities

• Provides support to research operations and IT on the interpretation of corporate and regulatory requirements (standards/policies/procedures) related to software validation, quality management, and GxP and oversees quality activities related to software, process, and data integrity validation
• Provides review of validation life cycle documents including validation assessments, 21 CFR Part 11 assessments, system validation plans, risk management plans, and validation summary reports in adherence with SOPs, corporate policies, standards, and government regulations to ensure completeness and accuracy
• Provides support of quality guidance through the cycle of preparation, execution, data analysis, and report writing for IQ, OQ, and PQ protocols
• Assists with periodic review of system documentation according to defined schedule to ensure continued compliance with SOPs, corporate policies, standards, and government regulations
• Provides quality review of related to changes that impact validated systems and/or processes
• Other duties as assigned

Skills

• This is a remote position based in the US; relocation assistance and visa sponsorship are not available
• Bachelor's Degree required; professional qualified experience may be substituted for education
• Direct experience in QA/QC role in computerized systems validation
• 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
• Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc
• Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles
• Experience in GCP clinical space, such as CRO or SMO, is highly preferred
• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred

Qualifications

Must Haves

• This is a remote position based in the US; relocation assistance and visa sponsorship are not available
• Bachelor's Degree required; professional qualified experience may be substituted for education
• Direct experience in QA/QC role in computerized systems validation
• 3+ years' professional work experience in a clinical research, biotech, or pharmaceutical environment focused in FDA GxP requirements for systems, 21 CFR Part 11 and FDA software validation guidelines
• Knowledge of industry and international standards for software quality, such as GAMP V, PIC/S, ICH, etc
• Knowledge of pharmaceutical, biologics, CRO, and clinical sites 21 CFR Part 11 requirements and software validation principles

Nice to Haves

• Experience in GCP clinical space, such as CRO or SMO, is highly preferred
• Experience and knowledge of EU regulations, e.g., Annex 11 is preferred

Benefits

• Fully remote position based in the US
• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being
• An annual bonus or long-term incentive opportunities may be offered