Keith Haarmeyer

Background

About Keith Haarmeyer

As part of the Doheny Image Reading Center (DIRC) leadership team, oversaw the Software Development and Validation teams in support of Doheny Eye Institute and the (DIRC) clinical trials system(s), ophthalmology systems, and supporting business applications. GxP/ICH/FDA regulations (inc.21 CFR Part 11 & GAMP) Led the development, deployment, and system transition of multiple major/minor product releases for ARCOS (Application for Reading Center Operations and Submissions)(8+); An in-house custom developed enterprise level 21-CFR Part 11 compliant Clinical Trials Management System (CTMS)/Laboratory Information’s System (LIMs). Responsible for the delivery of ARCOS starting with V1.0, which replaced a paper-based clinical trials process to a fully automated web and windows platform that included (but not limited to): Internally developed eCRF document system and eSignature Image Submission Visit Management Patient Tracking Reports Operations, Development, and IT liaison; ensuring dynamic communications between developers and end users to ensure product delivery met user expectations, while maintaining source code and database integrity. Integrated Technology Services, technical staff, and security vendors for building system, application, database architectures based on risk, security, compliance, and business needs. Business and project leaders across the center; Led a team of change managers, training, communications, and professionals on change activities related to system transition. Detailed Hands-on experience with the full System Development Life Cycle (SDLC): Planning & Business Requirements UX Design and Configuration Specifications Server/Application/Database Architecture Evaluating Security, Risk and System Compliance (including regulatory compliance; GxP, GDPR & data minimization) Training Developed key strategic initiatives with CI/CD/System updates that increased operational efficiencies and lowered costs with a goal of continuous improvement based on tracking metrics, internal and external needs, and evaluating quality issues (departures, deviations, environmental changes). Work closely with Quality Assurance and Compliance to implement to migrate Quality Management system to an eQMS (IQVIA SmartSolve system). In-room (on-site and remote) audit experience (vendor and clinical trial sponsor audits).