Experience

SynAgile
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Associate Director, Clinical Affairs

  • Aug 2022 - Present

Johnson & Johnson
• Law Practice
• 1 - 100 Employee
• Global Trial Lead

  • Feb 2022 - Jul 2022

MEI Pharma
• United States
• Biotechnology Research
• 1 - 100 Employee
• Associate Director, Clinical Operations

  • Oct 2019 - Feb 2022

Intercept Pharmaceuticals
• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee
• Sr. Manager, Clinical Operations

  • Jul 2018 - Oct 2019


Confidential Client

• Advertising Services
• 1 - 100 Employee

• Clinical Operations Strategist

  • Mar 2018 - Jul 2018

  Managed Clinical Operations at a mid-sized biotechnology company with FDA Regulatory Strategies for Phase I - Phase IV Clinical Trials. Worked under non-disclosure. Managed Clinical Operations at a mid-sized biotechnology company with FDA Regulatory Strategies for Phase I - Phase IV Clinical Trials. Worked under non-disclosure.



Head Consulting Inc.

• United States
• Information Technology & Services

• Sr. Principle Consultant (Nov 2017-Mar 2018 UCSD Neurology Department)

  • Dec 2017 - Mar 2018

  Neurology is the latest Therapeutic Area of Expertise in which Head Consulting, Inc provides clinical services. - Study start-up for Neurology Studies in Alzheimer's Disease - Responsible for site selection process - Responsible for fully planning and managing all aspects of the Investigator's Meeting by hosting Neurologists and representatives from corresponding sites that will be a part of multiple Phase 2 Clinical Trials in 2018 Neurology is the latest Therapeutic Area of Expertise in which Head Consulting, Inc provides clinical services. - Study start-up for Neurology Studies in Alzheimer's Disease - Responsible for site selection process - Responsible for fully planning and managing all aspects of the Investigator's Meeting by hosting Neurologists and representatives from corresponding sites that will be a part of multiple Phase 2 Clinical Trials in 2018



Senhwa Biosciences

• United States
• Biotechnology
• 1 - 100 Employee

• Associate Director of Clinical Operations & Regulatory Affairs

  • Oct 2016 - Oct 2017

  - Received Orphan Drug Designation for Phase II drug for Cholangiocarcinoma. - Identified qualified resources and managed the hiring process in which I hired and on-boarded current Vice President of Clinical Operations. - Managed entire process to update amendment to protocol for Randomization Phase 2 Study. - Received Orphan Drug Designation for Phase II drug for Cholangiocarcinoma. - Identified qualified resources and managed the hiring process in which I hired and on-boarded current Vice President of Clinical Operations. - Managed entire process to update amendment to protocol for Randomization Phase 2 Study.



Abbott Molecular Inc.

• Consultant Project Manager FDA TMF Compliance and Document Control Specialist

  • Nov 2015 - Sep 2016

  - Point of contact for pivotal FDA inspection before closing operations in Aug 2016. - Preparation Lead for FDA inspection. - Point of contact for pivotal FDA inspection before closing operations in Aug 2016. - Preparation Lead for FDA inspection.



PAREXEL International through Ashley Head Consulting, LLC

• Project Manager/Project Associate/Clin. Document Specialist/Clinical Scientist

  • Jan 2012 - Jun 2015

  - Provide support to International Clinical Document Control Group in Toronto, Canada - On-board and Off-board new hires as needed - Overall responsibility for processing, tracking, and managing client deliverables on a project - Train Team Members on how to enter time and task details for a Project; explain any nuances - cGMP & PMO lead - Provide support to International Clinical Document Control Group in Toronto, Canada - On-board and Off-board new hires as needed - Overall responsibility for processing, tracking, and managing client deliverables on a project - Train Team Members on how to enter time and task details for a Project; explain any nuances - cGMP & PMO lead



Otsuka Pharmacueticals

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Consultant/Project Manager/ Clinical Document Control Specialist (PAREXEL)

  • Oct 2011 - Jun 2012

  - Manage Federal Clinical Procedural Documents originating from the USA and Japan for standard USA technical formatting for Clinical Trials on Humans. - Preparation and formatting of Standard Operating Procedures. - Maintenance of the Training Documentation for all Company Operations. - Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies. Show less



Pfizer

• Events Services
• 1 - 100 Employee

• Clinical Project Manager Oncology Studies

  • Oct 2007 - Oct 2011

  - Maintain and coordinate the logistical aspects of a pivotal Phase III Clinical Trial (Sutent) Clinical Trial according to GCPs and relevant SOPs. - Manage 24 staff, vendors/CROs to ensure compliance with all protocol and pre-clinical study requirements. - Maintain and coordinate the logistical aspects of a pivotal Phase III Clinical Trial (Sutent) Clinical Trial according to GCPs and relevant SOPs. - Manage 24 staff, vendors/CROs to ensure compliance with all protocol and pre-clinical study requirements.



Abbott Laboratories, GRDP

• Contract Clinical Data Manager

  • Dec 2006 - Jun 2007

  - Design and review Case Report Forms (CRFs) from protocols. - Create and review validation check specifications and test databases and validation checks; setup and review databases. - Perform discrepancy management; perform quality control checks. - Maintain and review study documentation, act as a liaison between cross functional areas. - Perform QC review of study data prior to study release. And reported inaccurate findings. - Design and review Case Report Forms (CRFs) from protocols. - Create and review validation check specifications and test databases and validation checks; setup and review databases. - Perform discrepancy management; perform quality control checks. - Maintain and review study documentation, act as a liaison between cross functional areas. - Perform QC review of study data prior to study release. And reported inaccurate findings.



Ben Taub General Hospital

• United States
• Higher Education
• 1 - 100 Employee

• Research Assistant

  • Aug 2004 - Dec 2006

  - Patient recruitment for methylprednidsolone study. - Maintain, update and assist in testing the Oracle Clinical/Hospital Database. - Identify, resolve or query problematic data observed during data entry raised by electronic checks or manual review. - Collect blood specimens to send to laboratory for analysis. - Collect blood samples to centrifuge and record relevant results. - Patient recruitment for methylprednidsolone study. - Maintain, update and assist in testing the Oracle Clinical/Hospital Database. - Identify, resolve or query problematic data observed during data entry raised by electronic checks or manual review. - Collect blood specimens to send to laboratory for analysis. - Collect blood samples to centrifuge and record relevant results.



Emory Medical Hospital

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Student Apprentice

  • May 2001 - Jun 2004

  - Enter changes/updates to the hospital database from Data Clarification Forms. - Enter DCF's into Oracle Clinical database. - Maintain open communication with mentor. - Keep daily log of research tasks completed. - Learn medical terminology while applying it to everyday professional conversation. - Maintain Inspection Readiness documents in study team shared space. - Enter changes/updates to the hospital database from Data Clarification Forms. - Enter DCF's into Oracle Clinical database. - Maintain open communication with mentor. - Keep daily log of research tasks completed. - Learn medical terminology while applying it to everyday professional conversation. - Maintain Inspection Readiness documents in study team shared space.