Elizabeth C.

Experience

• 

  Eli Lilly and Company

  Jun 2006 - Jun 2014

  • Process owner for SDE/SD2i drug development process for all Phase II-IV trials. • Clinical Trial Manager that worked with China affiliate to build the team and train on the delivery model. This process resulted in a decrease of 4-6 months off China FPV.• Led and coordinated critical activities to ensure compliance throughout the process: gap assessments, commitments, response to audit & inspection findings and deviations. Clinical Trial Project Manager Consultant tasked to Mentor/ Train the CTM/PM/CPM position in the China affiliate. Daily project management mentoring on Lilly and PPM standards. Built a network of Subject Matter Experts on main topic areas that were dedicated to the China needs/issues. Set up an extensive training library on non-procedural processes. Successfully integrated into the China culture with continued support to the organization in China. Strategically lead a crossfunctional team to successful, ontime delivery of pase II-IV global clinica trials. Managed allclinical trial SAE's in the cardiovascul/ actue care theraputic portfolio ensuring on time reporting to global regulatory agencies.

  • SDE/SD2i (Study Development to Implementation) process owner

    Feb 2013 - Jun 2014

  • Consultant - Clinical Trial Manager

    Aug 2012 - Feb 2013

  • Consultant - Clinical Trial Project Management

    Mar 2010 - Aug 2012

  • Global Case Management Lead - Cardiovascular/ Acute Care

    Jun 2006 - Mar 2010
• 

  AbbVie

  Jul 2014 - Apr 2021

  • Oversee all aspects of AbbVie’s global case management enterprise, including financial management for a $50MM+ annual budget, and responsible for 200 US-based employees and 1,000 global-vendor staff.• Use automation and innovative technologies to drive business process and operational excellence.• Establish and implement standards of care based on hospital and regulatory agencies standards and performance requirements.• Business lead for Innovation and Automation work stream with investment in RPA, NLP, Hosted safety database, Flexi-xml. • Work with leadership and internal stakeholders to identify and recommend process and quality improvement activities/strategies and create implementation plans ($200M in cost avoidance).• Leading team that has deployed 10 bots including RPA and Machine Learning. • Chair for Women Leader's in Action Employee Resource Group. Show less • Managed a team of 5 direct reports and 150 employees that supported the case processing organization and provided consistent and accurate delivery of high quality, relevant and timely adverse event information.• Proactively identified, evaluated, developed, and implemented process optimization and process improvement initiatives that resulted in quality and productivity improvements to global adverse processes, systems/databases, and reporting.• Ensure compliance with policies/procedures and that high-quality standards were maintained in accordance with local, state, and federal requirements.• Chair for Women Leader's in Action Employee Resource Group. Show less • Planned, organized, and shaped day-to-day pharmacovigilance care practices in the areas of Neuro, Cardiac, Renal, Metabolic, Men’s Health, Women’s Health, Pain, and devices.• Ensured accurate and timely tracking and reporting of team deliverables and identification, communication and management of team risks, issues, and opportunities.• Served as a key business partner for other disciplines and drove cross-functional alignment and good decision-making practices. • Women Leaders In Action Events Chair 2016. Show less

  • Senior Director Global Case Management and Patient Data Intake

    Oct 2017 - Apr 2021

  • Director Medical Safety Surveillance

    Apr 2016 - Oct 2017

  • Associate Director

    Jul 2014 - Apr 2016
• 

  AMPLIO HCI, Inc.

  Apr 2021 - May 2021

  Consultant

  Co-Owner, Vice President Life Sciences

• 

  Aimmune Therapeutics, a Division of Nestle Health Sciences

  May 2021 - Jul 2022

  Senior Director, Safety Operations and Infrastructure

  Accountable for the identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to ensure quality and consistency in safety operations, data output, studies and programs.Responsible for implementing and maintaining safety database, safety data standards, safety data quality, case processing and follow-upVendor selection, oversight and creating a strategic vendor partner relationship.stakeholder management across safety medical team to implement and support appropriate analysis tools for safety data from studies and post marketing environments.Sherpa for the aggregate report process, managing process to support accurate data outputs and timely delivery.Manage the budget for for PPSRMLead SME for Inspections and auditsKey Liaison to Clinical Operations; Clinical Medical; Regulatory; Compliance; HR and Senior leadership team. Show less

• 

  Day One Biopharmaceuticals

  Jul 2022 - now

  Operations management, oversight and delivery across PV and Clinical Operations. Responsible for the strategy and delivery of PV operations and compliance to global health authorities.

  • Vice President, Development Operations

    Oct 2023 - now

  • Sr. Director PV Operations and Compliance

    Jul 2022 - Oct 2023