Martin Mansfield Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Namur, B-, Be

Retraining for the next phase of my career: * Evyrgreen AI training to learn AI techniques for networking and posting in LinkedIn (completed 31JAN2024).* Completing Cloud Bootcamp training course to attract contract work supporting multi-cloud (AWS, Azure, GCP, OCI,DevOp) digital transformation, M&As, CSV process consolidation, and regulatory defense of cloud-based computer systems (in progress).

Durham, North Carolina, Us

Implemented IQVIA's validation document access portal for large Sponsors (> $100M/year) to reduce document preparation and review times for PAI of drugs post-clinical study. Leveraged IT systems to provide near-real time access to validation documents, reduce audit frequencies and reduce audit costs by 10%.Represented IQVIA in 50+ sponsor audits of SLC/CSV deliverables to win new business and protect current revenue streams of $50M+/year.Trained global staff in CSV and technical writing for validation deliverables to meet IQVIA's goal of Right-First-Time, No-rework.Revised/authored CSV Documents for 15 Clinical Operations computing systems to meet Sponsor and regulatory requirements.

Implemented paperless qualification of Cloud infrastructure using automated scripts and DevOps, reducing qual. times by 25% .Validation of a bespoke Risk Categorization and Assessment Tool for Risk Based Quality Management (RBQM) to target risk areas and reduce study completion time/cost.Qualified of Alation (ML tool) which builds clean, big data catalogs for consumption in the Corporate Data Lake.Qualified Innoplexus AnalytiKa (AI/ML tools) to mine relevant documents and analytics from various public clinical data sources.Qualified ConcertAI (AI tool) that builds cohorts for trial feasibility and research execution from real world oncology data.Improved employee retention of GCP concepts by transforming static training to an engaging learning experience using AI tools (Qstream, Trivie).

Waltham, Ma, Us

M&A - Performed regulatory gap assessments on IT technology and GxP computer systems and delivered validation plans for the system integration of Viral Vector, mRNA-based, and plasmid DNA vaccine sites, plus protein manufacturing sites into Thermo Fisher's pharmaceutical services group to reduce overall validation execution times by 25%.Active Directory Refactoring Project - Completed re-architecture, infrastructure qualification and document development of the Thermo Forest, DCs, domains, OUs and GPOs for 650+ ThermoFisher sites. Reduced domain costs by 25%.Developed Quality Management System (QMS) for Thermo Fisher's Qualification Life Cycle (QLC) in the Pharma Group; assured compliance of IT security polices with FDA, MHRA and EMA guidelines for regulatory inspection.Performed Quality Management Reviews (QMRs) by monitoring global enterprise IT infrastructure using 25 custom Key Performance Indicators (KPIs) based on GAMP5, the US CFRs and EudraLex,Vol. 4, Annex 11.Developed/implemented Thermo Fisher's global IT vendor audit process and applied it to AWS, Azure, SAP/SF-LMS, and GitHub to close a critical FDA CAPA.Developed/implemented Thermo's global IT vendor audit process and applied it to AWS, Azure, SAP/SF-LMS, and GitHub to close a critical FDA CAPA.

Ludwigshafen, De

Authored the System Development Life Cycle (SDLC) to meet EPA regulatory guidelines for the functional and design requirements and system/user acceptance testing.Assessed the appropriate risk levels for requirements so that high risk functions in computer systems are adequately tested and any risk to BASF's revenue stream are <10%.Maintained traceability of test cases to requirements and test workflows for reusability and regulatory inspection and to reduce findings to 0.Tracked/reported/retested/closed defects found during validation cycles and present statements to senior management regarding the quality of BASF computer systems.Interacted directly with EPA/FDA authorities to discuss current validation issues and place BASF in the forefront of compliance with the Code of Federal Regulations and OECD.

Durham, North Carolina, Us

Implemented Unified Functional Test (UFT) for the automation of clinical trial applications using Siebel, Web and .NET add-ins. Reduced testing time by 30% through automation and reusability of automated scripts.Automated the validation of Clinical Trial Management systems and Clinical CRM business applications developed in Siebel 8 and Java/Spring using Agile and Waterfall methodologies.Validated the DCRI's first Data Warehouse/Dashboard applications using Informatica ETL middleware to extract, transform and load from multiple application data sources; applications include multimilliondollar Hep C trials and DCRI Business reporting.

Multicloud Bootcamp

Doctor Of Philosophy (Phd), Analytical Chemistry + Computer Engineering

Bachelor Of Arts (Ba), Biology, General + Chemistry