Kim Oldham

About Kim Oldham

Senior clinical research professional with a broad base of experience in quality assurance, data management, project management, and technology implementation for Phase I-IV pharmaceutical research.Skilled quality assurance auditor who has conducted over 60 audits, with deep expertise in Computer System Validation (CSV), data management, biostatistics, data integrity, and GCP compliance. Skilled in auditing clinical and digital systems for 21 CFR Part 11 adherence and ALCOA+ principles. Provides clear, objective assessments to identify gaps, mitigate risk, and ensure inspection readiness. Experienced with vendor/supplier, for cause, sponsor, project, and internal process audits.Experienced in design of global quality systems, including gap analysis, regulatory compliance assessment, and harmonization of multiple systems into a single quality system; creates processes for compliance and efficiency and seamless integration of the clinical trial process.Proactively identifies workflow and process issues; collaborates with subject matter experts to create and execute plans/processes for improvements.Specializes in oversight of CSV activities for a CRO, including training of process and system owners.Ensures the needs of clients, stakeholders, employees and patients are met in a responsible and ethical manner regarding regulatory responsibilities.

Experience

1. Senior Auditor

   Gxp Engaged

   Feb 2026 — Present · Chicago, IL, US

   Discusses assigned audit requirements with the assigned Project Manager• Conducts all assigned project-related tasks (planning, performance, reporting and/or follow-up); schedulesappointments as necessary for the conduct of such activities.• Discusses significant findings with a Managing Director or Project Manager, for example for critical findings.• Writes the audit report according to timelines for peer review and approval.• Mentors and oversees new/junior Auditors.

Education

• University of Illinois Chicago

  Master’s Degree, Human Nutrition and Dietetics

• The University of Texas at Austin

  Bachelor of Science - BS, Human Nutrition

Skills

• Ich-Gcp
• Oncology Clinical Research
• Clinical Trials
• Clinical Data Management
• Biotechnology
• Clinical Research
• Clinical Operations
• Validation
• Clinical Development
• Nutrition
• Gcp
• Electronic Data Capture (Edc)
• CRO Management
• CRO
• Data Management
• Program Management
• Edc
• Biostatistics