Experience

Pharmaron

• China
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager Study Start Up

  • Nov 2022 - Present



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Area Study Start Up Lead IV

  • Nov 2021 - Nov 2022



Covance

• United States
• Research Services
• 700 & Above Employee

• Senior Site Selection Lead

  • Oct 2020 - Jan 2022



Worldwide Clinical Trials

• United States
• Research Services
• 700 & Above Employee

• • 2020 - Oct 2020

  Serve as the primary point of accountability and contact for all start-up activities on assigned projects• Oversee, coordinate and drive the activities of Site Activation Specialists, Regulatory Specialist and Site Contracts specialists on assigned projects to ensure critical path activities completed on time• Coordinate with the Site Management and Project Management departments to achieve on time site activations• Coordinate with other Site Activation and Regulatory Leads to prioritize activities across projects and ensure the optimal start-up of assigned projects in the start-up phase• Work closely with the assigned LCRA and GPL to expedite the Site Qualification and Selection process as well as the project transition from the startup phase to the conduct phase• Coordinate and provide project level status reporting to GPL and Sponsor as appropriate• Perform and prepare risk assessment and mitigation plans relating to departmental deliverables• Escalate issues to functional units as necessary to ensure resolution and minimize risks to on-time deliverables• Work in conjunction with the assigned LCRA and GPL to develop study-specific Site Activation Plan which includes all activities required to activate sites for a specific study ensuring each task has a clear owner and due date• Liaise with other functional contributors and vendors as needed• Develop, review, maintain SOPs and best practice guidelines and provide training pertaining to activities of the Site Activation department• Lead/provide input to departmental process improvement initiatives• Support the sales process by contributing to proposals and bid defense meetings• Collation and maintenance of site activation metrics• Manage assigned direct reports Show less

• • Apr 2019 - Oct 2020



PPD

• United States
• Research Services
• 700 & Above Employee

• Sr SIA Team Manager

  • Sep 2018 - Apr 2019



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Study Start Up Lead 2

  • Jun 2017 - Sep 2018



INC Research

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior SSU and Regulatory Specialist

  • Aug 2016 - Jun 2017



PRA Health Sciences

• United States
• Research Services
• 700 & Above Employee

• Study Start Up Lead

  • Jan 2015 - Aug 2016



Global Study Start Up Specialist II

• Cary, NC

• InVentiv Health

  • Dec 2012 - Jan 2015

   Research local requirements for documentation of IRB/EC submission approvals and subsequent follow-up documentation.  Liaise with study sites regarding essential document collection and, as required by country, site contract/budget negotiations.  Assist with IRB/EC submissions as required.  Arrange/review translations of regulatory documents as required.  Arrange/review translations of regulatory documents as required.  Customize country/site specific Patient Information Sheet and Informed Consent forms.  Review Study documents as required, e.g. patient directed materials.  Provide regular local status updates to GSSU manager; updates appropriate study tracking tools with local essential document and ethics committee status when required.  Assist project teams with site selection activities as required.  Ensure all relevant documents are submitted to the Trial Master File (TMF) as per PharmaNet/i3 SOP/Sponsor requirements.  Provide updates of local processes and requirements to Regulatory Intelligence portal.  Provide support, mentoring and training to junior staff. Show less



inVentiv Health Commercial

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Global Study Start Up Specialist

  • Dec 2012 - May 2014

   Research local requirements for documentation of IRB/EC submission approvals and subsequent follow-up documentation.  Liaise with study sites regarding essential document collection and, as required by country, site contract/budget negotiations.  Assist with IRB/EC submissions as required.  Arrange/review translations of regulatory documents as required.  Customize country/site specific Patient Information Sheet and Informed Consent forms.  Review Study documents as required, e.g. patient directed materials.  Provide regular local status updates to GSSU manager; updates appropriate study tracking tools with local essential document and ethics committee status when required.  Assist project teams with site selection activities as required.  Ensure all relevant documents are submitted to the Trial Master File (TMF) as per PharmaNet/i3 SOP/Sponsor requirements.  Provide updates of local processes and requirements to Regulatory Intelligence portal. Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Feasibility Coordinator

  • Apr 2010 - Dec 2012

   Developed and Analyzed data from various databases and platforms including Clinical Trials.gov, Salesforce and various outside sources.  Developed and maintained tracking systems for Feasibility Data and questionnaires List duties in past tense.  Assisted in the development and launch of Feasibilities questionnaires.  Worked closely with Feasibility Specialists in the assessment and coordination of Feasibility results.  Maintained Feasibility information and data resources within the Clinical Trial Management System and train and educate Country level Feasibility associates regarding procedures. Show less



PPD

• United States
• Research Services
• 700 & Above Employee

• Project Assistant

  • Dec 2007 - Apr 2010

   Reviewed regulatory documents for proper content in accordance with FDA, ICH/GCPs, PPD and client company appropriate SOPs prior to submission to the Project Manager, central IRB, Regulatory Affairs and/or the client.  Performed PPD investigator file reviews and logged outstanding issues in project related tracking tools.  Liaised with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory review and investigator file reviews in a timely manner.  Developed and maintained assigned data points within the CTMS database according to the established conventions and tools for the project, within specified timelines.  Oversaw the execution and dissemination of study related information, including project tracking updates to clients, clinical study teams and other PPD departments Show less