Experience

SynAgile

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Associate Director, Clinical Affairs

  • Aug 2022 - Present

  Indication: Neurology (Parkinson’s Disease) - Drug + Device This position reports to the CEO and works closely with the VP of Clinical Affairs and cross-functional team members, external key opinion leaders, patient advocacy organizations, CROs, clinical sites, and consultants to ensure the appropriate scientific rigor in the Clinical Affairs program. • Drives the preparation of the Human Factors requirements, together with VP of Clinical Affairs • Completes detailed review of study documents (and amendments) and provides robust operational input to ensure the study is operationally feasible and patient considerate • Translate research concepts/strategies into specific clinical objectives and activities to ensure program success • Able to work in a fast-paced environment with experienced combination-product professionals and able to respond to changing priorities in a thoughtful, creative manner • Collaborates closely with QA and Engineering Executive Managers • Ensure trial is running according to timelines, quality, and budget • Oversees deliverables of all cross-functions are on time • Creates/updates/reviews budget forecasts • Review and interpret clinical study data and contribute to clinical study reports, abstracts, and manuscripts as required • Supports creation/review of external communications to sites (supports/drive/creates clinical trial materials together with CRO) • Remain up to date with therapeutic area science, competitors, regulatory requirements and guidelines • Ensure all clinical activities are delivered in accordance with expectations, trial protocol, ICH/GCP guidelines and applicable SOPs and regulations • Reviews CSR: methodology & quality sections, at minimum • Attend conferences to meet attendees, sponsors and other stakeholders as a way to provide organic business development to SynAgile Corporation Show less



Johnson & Johnson

• Law Practice
• 1 - 100 Employee

• Global Trial Lead

  • Feb 2022 - Jul 2022

  Indication: Oncology (Prostate Cancer) - Drug The Global Trial Lead ("GTL") is accountable for oversight of external service providers, planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document (PED) to availability of the Clinical Study Report (CSR) and applicable disclosure of the trial results. The GTL is responsible for leading the cross-functional Trial Team (including LCI/NV and cross-sector members) and interfaces with all trial team members, building the trial operational plan, is responsible for ESP contracts and budget, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team (CT)'s objectives. The GTL provides global operational leadership to the execution to plan and defines risk mitigation strategies and ensures implementation thereof. • Develops and maintains External Service Provider Plan (ESP). • Maintains oversight of vendors, including documentation of meetings/outcomes in minutes or equivalent tracker • Develops Sample Management Plan together with functions • Oversees Annual Quality Review • Builds study timelines (MS Project template expected /available) • Maintains cross-functional oversight of deliverables • Attend Clinical Management Working Group (CMWG) meetings to oversee signals/trends and actions that are taken by CTMs and team • Ensures proper focus and prioritization to activities that support the primary endpoint • Maintains clinical registry information (e.g., Clinicaltrials.gov- including CTMS, JJAR required fields are up to date and any changes to ‘Primary Completion Date (PCD), expected’ are communicated to CT/CDT prior to edit) • Supports team communication in some format useful to stakeholders (e.g., periodic summary email, dashboard/exec summary) Show less



MEI Pharma

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director, Clinical Operations

  • Oct 2019 - Feb 2022

  Indication: Oncology Blood Cancer - Drug Reported to the Vice President of Clinical Operations while independently managing a Phase I, II, and III clinical trials. Served as the sole Data Protection Officer ("DPO") for the company and GDPR subject matter expert. Also, I served as the corporate point of contact for all clinical trial insurance. Managed staff. • Managed the development, maintenance and tracking of clinical program plans including timelines, budgets, and resource requirements • Oversee assigned clinical program budget and liaise with Finance/Accounting in communicating budget forecasting and accruals • Develop Request for Proposals (RFPSs) and define scope of services for outsourced clinical activities • Evaluate, summarize, and compare various potential vendors’ proposals (e.g., CROs’ study proposals), including scope of services, budgets, and timelines • Coordinate CRO/vendor selection process activities, seeking input from other internal functional groups • In vitro diagnostics (IVDs) for blood type identification and blood cancer screening • General Data Protection Regulation (GDPR) SME for MEI • Manages all Clinical Trial Insurance for all clinical studies at MEI • Ensure qualification of CROs, vendors and service providers in accordance with MEI Pharma’s SOPs • Manage CRO/vendor agreements, ensuring change orders and budgets meet defined clinical operations specifications • Coordinate all vendors’ activities involved in the clinical trials, e.g., central lab, CROs, to ensure overall clinical program timelines are objectives are achieved Show less



Intercept Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Sr. Manager, Clinical Operations

  • Jul 2018 - Oct 2019

  Indication: Non-Alcoholic Serosis of the Liver - Drug Managed a phase I and II clinical trial from study start-up to CSR for the phase I. • Functions as the Study Team Lead (STL) in managing the clinical operations team and crossfunctional clinical team in the planning, execution, and reporting of clinical trials • Study Team Lead for the Phase I Cholestasis study with expected CSR August 2019 • Experience/knowledge of drug development from pre-IND through Phase I-IV clinical trials (NDA/BLA) • Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs • Coordinates vendor meetings and review vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy • Develops Clinical Programs and Project Plans to include timelines and milestones • Extensive experience managing CROs and budgets for vendors • Prepares Clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard • Operating Procedures, guidelines, and departmental policies Show less



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. • Manages vendors and provides vendors updates of the study-related documents including required signatures from site personnel • Initiates and participates in leading cross-functional or interdepartmental strategic initiatives and process improvements • Oversee site budget negotiations • Interviewed, hired, and provided input on scope of work for four Project Managers and seven CRAs through Site Initiation Visits of 35 sites (11 virtual) • Interacting with regulatory agencies, in concert with the Regulatory Affairs Department, to develop novel and efficient clinical programs in rare disease (Alzheimer’s disease) populations • Leading action-oriented, project team meetings and periodic project reviews including setting appropriate agendas and approving actionable minutes • Planned two Investigator Meetings with Principle Investigators Show less



Head Consulting Inc.

• United States
• Information Technology & Services

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

  • Dec 2017 - Mar 2018

  Indication: Neurology - Drug 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 II Clinical Trials in 2018 Indication: Neurology - Drug 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 II Clinical Trials in 2018



Senhwa Biosciences

• United States
• Biotechnology
• 1 - 100 Employee

• Associate Director of Clinical Operations & Regulatory Affairs

  • Oct 2016 - Oct 2017

  Indication: Phase I-IV (Oncology) - Drug Reported to the VP of Clinical Operations and Regulatory Affairs. I served as the interim VP for five months. • 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 II Study. Indication: Phase I-IV (Oncology) - Drug Reported to the VP of Clinical Operations and Regulatory Affairs. I served as the interim VP for five months. • 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 II Study.



Abbott Molecular Inc.

• Consultant Project Manager FDA TMF Compliance and Document Control Specialist

  • Nov 2015 - Sep 2016

  Indication: Phase I-IV (Oncology + Rare Diseases) - Device • Point of contact for pivotal FDA inspection before closing operations in Aug 2016. • Preparation Lead for FDA inspection. • Manages vendors and provides vendors updates of the study-related documents including required signatures from site personnel • Initiates and participates in leading cross-functional or interdepartmental strategic initiatives and process improvements • Participates in the development and review of study plans, brochures, study reports, protocols, • Reviews study related materials including, but not limited to monitoring reports, Clinical Brochures, and updates to the Protocol • Responsible for oversight of documents provided by other CRAs and provide secondary review of all aspects of these clinical trial documents to ensure proper filing of TMF and that it follows SOPs and FDA and ICH/GCP Guidelines • Regulatory document collection (Financial Disclosures) for Regulatory Affairs Department • Management and inventory of clinical supplies (non-investigational) • Work with the team to select investigational sites with input from Project Director • Oversee investigative sites adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and ensuring that active communication with the sites is conducted • Manage CRO's and vendors as well as assisting in site management • Oversee the submission of trial-related and essential documents to the Trial Master File Show less



PAREXEL International through Ashley Head Consulting, LLC

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

  • Jan 2012 - Jun 2015

  Indication: (Phase IV) - Oncology • The position reports to the Clinical Directors and Sr. Global Operations details of FDA Audit Preparation • Independently manage workflow of a staff of 30-50 Scientists who are reviewing Critical Documents in preparation of FDA Audits • Responsible for maintenance and enhancement of teams SharePoint site • Responsible for tracking and coordinating all project management standard compliance activities • Responsible for assisting and training EDC project managers on the use of templates and the understanding of approved processes • Independently prepare, conduct, report, metrics, and follow-up with CROs per the departmental SOPs, to prepare for FDA audits • As a leader of the FDA Audit Preparation Team, ensure that timely metrics are sent to all crossfunctional leads • Lead routine and eTMF meetings to perform spot audits of vendor eTMF • Liaison with Regulatory Affairs and Management support management and investigation of cases of scientific misconduct (PIs, sites, etc.) Show less



Otsuka Pharmacueticals

• United Kingdom
• Pharmaceutical Manufacturing
• 1 - 100 Employee

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

  • Oct 2011 - Jun 2012

  Indication: (Phase III) - Rare Diseases • 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

  Indication: (Phases I-IV) - Gastroenterology/Oncology • Maintain and coordinate the logistical aspects of clinical trials per GCPs and relevant SOPs • Manage 24 staff, vendors/CROs to ensure compliance with all protocol and pre-clinical study requirements • Capture (EDC) components for clinical research studies and act as Point of Contact during Audits • Retrospectively, ensure 1572s and related documents are uploaded to Trial Master File by study sites • Collect all information for NDA and other Regulatory submissions • Quarterly Quality Control of Trial Master File documents i.e., 1572s, IRB related docs and all NTF’s (Note to Files) • Supervised the day-to-day activities of the research assistants at a departmental level ensuring efficient operations Show less



Abbott Laboratories, GRDP

• Contract Clinical Data Manager

  • Dec 2006 - Jun 2007

  Indication: (Phases I-IV) - Gastroenterology/Oncology • 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. Show less



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.