Beth Fallon

Experience

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  Genentech

  Nov 2001 - Feb 2020

  Update: Beginning January 2019I was the US CPTS Manager supporting compliance, process, training and systems for Country Clinical Operations. I have 8 direct reports who sit in South San Francisco, CA and Mississauga, Canada. I reported directly to the CCO US Country Head and sat on her leadership team.We support compliance, process, training, systems and communications in the quality and compliance space within Country Clinical Operations. I managed anywhere from 7 to 12 direct reports and sit on the country leadership team. Show less

  • Compliance Process Training and Systems Manager

    Jul 2015 - Feb 2020

  • Head, Service Provider Management, CDM

    May 2014 - Jun 2015

  • Head, Process and Training Management

    Oct 2009 - Jul 2014

  • Manager, Training Innovation Process and Standards

    Feb 2007 - Oct 2009

  • EDC Project Manager

    Feb 2006 - Feb 2007

  • Sr., Study Data Manager

    Nov 2001 - Feb 2006
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  Personal Consulting

  Feb 2020 - Sept 2020

  Consultant Process, Training, Systems and Compliance

  Process Management: Development of 6 key process areas supporting regulated business activities in the Biostatistics, Clinical Data Management, Technical Operations, and Statistical and Clinical Programming areas.Technical Writing: Working with functional leaders and Subject Matter Experts wrote, reviewed and adjudicated process documentation.Project Management: Ensured key project sponsors and stakeholders were informed of project status and upcoming project risks and mitigation steps.Compliance Assessments: Conducted robust assessments of current industry standards and regulated requirements governing business processes to ensure alignment of corporate business process and industry requirements and best practices. Show less

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  Exelixis

  Sept 2020 - Dec 2024

  Clinical Compliance Director

  Providing GCP process and compliance guidance/support by developing processes, SOPs, work instructions, and templates; CAPA facilitation; reviewing and contributing to study plans, inspection preparedness, and operational issues; and acting as a bridge across departments in resolving problems. We provide a platform for inquiries and compliance information sharing with a solutions-based approach.

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  Self Employed

  Dec 2024 - now

  Clinical Compliance, Risk and Process Management Consultant