Allison Bright, PhD

Experience

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  Maricopa County Public Defender

  Nov 2006 - Jan 2011

  Maricopa County, Administration (Publics Works & Public Defender)
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  Synexus US

  May 2012 - Apr 2019

  Learning Management System o Successfully lead the change management and implementation of a Learning Management System (LMS365) for the organization integrating the company from an entirely paper- based system into an electronic learning management system. o Successfully met regulatory and other standards for training compliance. o Overhauled paper-based courses and created SCORM packaged training to deliver and track training compliance virtually, where applicable.Training Strategy o Analyzed training data, data reports, and other types of training data to create a risk-based training program.o Lead facilitation groups for process improvement related to training to include Delphi assessment and trend analysis.o Development of a model for training based on gap analysis and organizational risk. o Developed tests, skills assessments, and other mechanisms to measure learning for both electronic and in person learnings.o Developed core competency framework for scientific based and quality roles o Developed a model for leadership training used to transition employees from independent contributors to management roles.Training Delivery o Developed New Employee Orientation for the organization and delivered this training in person quarterly.o Developed and/or facilitated in person training to include courses on leadership, communication, project management, and motivation. o Organizational change management support provided via coaching to leaders following acquisitions to include completing leadership assessment, coaching, change management training, and 1:1 support for leaders in the organization. o Administration, scoring, and 1:1 coaching on personality assessments and validated measures with leaders in organization to include Myers-Brigg, DISC, NEO-PI, and non-validated tools such as True Colors. Show less QA GCP AuditorInternal auditGood Clinical Practice (GCP) consultationRegulatory Inspections Mock HA Inspection & Inspection Readiness Performance based RCA/CAPA support Complex issue consultancyCoaching and Training Performance improvement to determine contractual and regulatory compliance on studies conducted at clinical investigator sites.Performance improvement to identify process and procedural improvement opportunities.Performance improvement to identify functional area or human capital improvement.Performance improvement on compliance and overall health of the quality system.Performance improvement based on quality and compliance-based risk detection activities.Performance improvement on internal audit and regulatory inspections outcomes.Performance improvement on organizational behavior related to organizational quality. Metrics visualization in Power BI Trend analysis, reporting, and risk identification Quality Data Review Risk model aligned to mission critical and strategic objectives. Show less Lead and managed a team of Source Document Specialists through the clinical trial source creation process.Trained and coached staff, managed team priorities, and insured documents were prepared in accordance to GCP, FDA, and regulatory guidelines. Synthesized phase II- IV clinical trial study protocols to create technical writings used to conduct and interpret study specific phase II-IV clinical trials. Technical writing includes preparation of source documents that assisted clinical study personnel in the delivery of quality assured research conducted for specified clinical protocols.Skills includes breaking down complex concepts and processes with ethos to study protocol while engaging creativity, formulating content specification, development, implementation and evaluation.Clinical Research Coordinator for Phase 3 -4 Clinical Trials conducted in Investigator Sites. Show less

  • Director, Organizational Learning & Development

    Jan 2016 - Apr 2019

  • Associate Director, Quality & Enterprise Learning

    Feb 2018 - Jan 2019

  • Associate Director of Regulatory and Source

    Nov 2015 - Jan 2016

  • Technical Document Manager/ Clinical Research Coordinator

    May 2012 - Nov 2015
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  Arizona Healthcare Executives (ACHE Arizona Chapter)

  Jan 2013 - Jan 2017

  Arizona Healthcare Executives Newsletter Editor / Membership Committee
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  Local College

  May 2013 - Apr 2015

  General Education Advisory Board Member
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  PPD ( AES Business Unit)

  Apr 2019 - Nov 2021

  Associate Director, Quality & Enterprise Learning, Quality Perspectives & Improvement

  QA GCP AuditorInternal AuditGood Clinical Practice (GCP) consultationRegulatory Inspections Mock HA Inspection & Inspection Readiness Performance based RCA/CAPA support Complex issue consultancyCoaching and Training Performance improvement to determine contractual and regulatory compliance on studies conducted at clinical investigator sites.Performance improvement to identify process and procedural improvement opportunities.Performance improvement to identify functional area or human capital improvement.Performance improvement on compliance and overall health of the quality system.Performance improvement based on quality and compliance-based risk detection activities.Performance improvement on internal audit and regulatory inspections outcomes.Performance improvement on organizational behavior related to organizational quality. Metrics visualization in Power BI Trend analysis, reporting, and risk identification Quality Data Review Risk model aligned to mission critical and strategic objectives. Show less

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  Thermo Fisher Scientific

  Jan 2021 - Dec 2023

  Associate Director, Business Optimization Support, Quality Assurance & Enterprise Learning

  QA GCP AuditorInternal AuditGood Clinical Practice (GCP) consultationRegulatory Inspections Mock Inspection & Inspection Readiness Performance based RCA/CAPA support Complex issue consultancyCoaching and Training Performance improvement to determine contractual and regulatory compliance on studies conducted at clinical investigator sites.Performance improvement to identify process and procedural improvement opportunities.Performance improvement to identify functional area or human capital improvement.Performance improvement on compliance and overall health of the quality system.Performance improvement based on quality and compliance-based risk detection activities.Performance improvement on internal audit and regulatory inspections outcomes.Performance improvement on organizational behavior related to organizational quality. Metrics visualization in Power BI Trend analysis, reporting, and risk identification Quality Data Review Risk model aligned to mission critical and strategic objectives. Show less

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  Parexel

  Feb 2024 - May 2024

  Senior Auditor, GCP/GxP Quality Assurance
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  Senior Quality Assurance Professional

  May 2024 - now

  Senior Auditor, GCP/GxP Quality Assurance