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Work Background
PicnicHealthVP/Head of Quality & Regulatory
Jan. 2023 - Jan. 2025United StatesInteractive quality & regulatory leadership for real world evidence (RWE), observational study management, software/product development; Quality & Regulatory functional head
FreelanceIndependent Quality & Research Enablement Advisor
Jan. 2022Clinical Quality, Software/Data Integrity, and Research Enablement consulting
Focused on emerging healthcare, technology, biotech, and data clients
Specialized in novel tech solutions, real world data/evidence (RWD/E), and non-traditional clinical studies
Spark Therapeutics, Inc.Senior Director, Clinical Quality Leader
Jan. 2021 - Jan. 2022Interactive quality leadership for Good Clinical Practice (GCP) and Good Pharmacovigilance Practices (GVP); Quality business partner for clinical development; Department head for Clinical Quality
Flatiron HealthSenior Director, Integrated Quality Management
Jan. 2016 - Jan. 2021New York, New YorkInteractive quality & regulatory leadership for clinical research, real world evidence (RWE), and healthcare provider software/services (e.g., electronic health records); accountable for clinical study management, computer system validation, & quality management; Quality department head
MesoblastSenior Manager, Research Quality Assurance & Compliance
Jan. 2014 - Jan. 2016Proactive quality support for clinical, non-clinical & safety for cell therapy development; quality management system ownership; quality planning and oversight for vendors
AllerganProgram Manager (Quality Assurance)
Jan. 2013 - Jan. 2014Risk-based quality support plans aligned to development strategy from early & late phase [Previously Forest Laboratories/Forest Research Institute]
Novo Nordisk IncManager, Quality Management
Jan. 2011 - Jan. 2013Training & quality support for clinical trial management; built clinical research associate (CRA) development program (including process guideline, templates, & training); inspection management
QuintilesSenior Site Manager (Sr CRA)
Jan. 2010 - Jan. 2011Expert in trial monitoring; train/mentor new CRAs; dedicated resource for Janssen
Paragon Biomedical (now Clinipace Worldwide)Quality Assurance Auditor
Jan. 2006 - Jan. 2010Auditing of global clinical sites, vendors, trial master files, & processes; quality management system ownership; facilitating partner audits; corrective/preventative action oversight
Corautus GeneticsClinical Research Associate (CRA)
Jan. 2006 - Jan. 2006Gene therapy trial monitoring & project management; oversight & management of trial master file as well as third party vendors; generated FDA clinical hold response resulting in release of hold [Cardiac Biotech (gene therapy)]
CIBA Vision (now Alcon)Clinical Research Associate (CRA)
Jan. 2003 - Jan. 2006Ophthalmic drug / medical device trial monitoring & project management; international site management; protocol & consent design; data management
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