Chris Merriam-Leith, Msqa, Msra, Pmp, Rac Email & Phone Number

Development of AI Clinical Analytics QMS FrameworkThe objective of the AI Clinical Analytics QMS Framework is to ensure the effective and compliant integration of AI technologies within clinical operations. This framework encompasses a comprehensive set of policies and procedures designed to enhance data integrity, security, and ethical use, while also focusing on AI software development lifecycle (SDLC) and computerized system validation (CSV) practices. Key elements include:• Clinical Trial Design and Operations: Employs AI to optimize clinical trial design, improve accuracy of forecasts, predict patient recruitment rates, and identify potential dropouts, thereby streamlining operations and enhancing trial efficiency.• AI Software Development Lifecycle (SDLC): Establishes rigorous standards for developing, validating, and maintaining AI software, ensuring technical compliance, performance reliability, and regulatory adherence.• Computerized System Validation (CSV): Defines processes for validating AI systems to guarantee their accuracy, reliability, and compliance with regulatory standards, thus ensuring patient safety and data integrity.• Risk Management and Quality Assurance: Implements policies for continuous monitoring, risk control, and quality improvement to mitigate potential AI-related risks and maintain high standards of performance and compliance.• Ethical and Privacy Considerations: Ensures the ethical use of AI, protects patient privacy, and fosters transparency and accountability in AI decision-making processes.• White Paper - AI Clinical Analytics• White Paper - AI Governance Practices in Biopharmaceuticals• White Paper - Navigating AI Privacy Regulations• White Paper - Integrating AI within Quality Management Systems

Santa Barbara, California Area

Highly accomplished and results-driven consultant with experience across various aspects of digital transformation consulting. Expertise in cloud technologies, data governance, with a deep understanding of their applications and implications for businesses. Strong legal background in privacy, data protection, and intellectual property laws, providing comprehensive guidance on compliance and risk management. Proven ability to translate complex regulatory and technical issues into practical solutions for clients, effectively bridging the gap between law, regulatory compliance, and technology. Extensive experience working with cross-functional teams and advising on strategic initiatives related to technology adoption, ethical considerations, and business planning. Excellent communication and interpersonal skills, enabling effective engagement with clients, stakeholders, and regulatory bodies. Proficient in managing multiple projects simultaneously and consistently delivering high-quality work under tight deadlines. Certified in regulatory governance and privacy by monitoring industry organizations, demonstrating a commitment to staying up to date with emerging trends and best practices.• Implemented, Veeva Vault Platform QMS, QualityDocs, LMS, RIM, eTMF, CTMS, Promomats, and security model auditing, document lifecycle analysis, covering various modules and ensuring compliance with regulatory standards. • Spearheaded quality and regulatory compliance projects, establishing strategic Quality Management System (QMS) governance aligned with FDA, EMA, and ICH guidelines. • Orchestrated the rollout of GxP QMS (GCP, cGMP, GLP, CSV), overseeing the creation and implementation of robust quality policies, SOPs, and business process optimizations. • Led cross-functional teams in the development of risk-based regulatory strategies, ensuring adherence to evolving global compliance standards.

United States

23andMeAbcuroAgenusAllogeneAngiodynamicsApellis BioArcutis BioArrowhead PharmaAruvant SciencesAstellas PharmaAudentesAudentes TherapeuticsAurinia PharmaAvanir PharmaAxsomeBetter TherapeuticsBiogen IdecBiomarin BioCoherus BioCrineticsCymabay TherapeuticsCytokineticsDynavax TechnologiesElan PharmaEvidationExelixis BioFate TherapeuticsFusion PharmaGenentechGlobal Blood Therapeutics (GBT)Google Life SciencesGossamer BioGreenwich BioGW BioGynesonicsHalozyme TherapeuticsImmunocore TherapeuticsJohnson & JohnsonKodiak SciencesKura OncologyLaronde TherapeuticsLovelace Respiratory Research (CRO)Mirati TherapeuticsMyonexus TherapeuticsNGM BiopharmaceuticalsNovartis PharmaNuvation BioOrchard TherapeuticsSangamo TherapeuticsSanofi Aventis PharmaShire / Baxalta PharmaSienna BioSierra OncologyTakeda PharmaUSC Medical CenterVaxcyteVir BioVivosenseZogenix

Master'S Degree, Quality Assurance

Activities and Societies: Thesis: The Applications of Blockchain Technology within Pharmaceutical Supply Chain and Quality Management.

Master'S Degree, Regulatory Affairs

Master of Science Regulatory Affairs (MSRA)

B.S. Business Administration, Specialization In Finance And Minor In Economics

Business Administration, Finance, Accounting and minor in Economics