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Tony Nguyen

Clinical Research Coordinator

Associate Director - Clinical Documentation at Nektar Therapeutics

San Francisco, California, United States

Section title

Tony Nguyen's Email Addresses & Phone Numbers

Tony Nguyen's Work Experience

San Francisco Clinical Research Center

Clinical Research Coordinator

October 2009 to March 2010

Ultragenyx Pharmaceutical Inc.

Manager- Clinical Systems and Records Management

April 2016 to August 2017

San Francisco Bay Area

Nektar Therapeutics

Associate Director - Clinical Documentation

San Francisco, California, United States

Tony Nguyen's Education

University of California, Los Angeles

Bachelor of Science (BS)

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About Tony Nguyen's Current Company

San Francisco Clinical Research Center

Frequently Asked Questions about Tony Nguyen

What company does Tony Nguyen work for?

Tony Nguyen works for San Francisco Clinical Research Center

What is Tony Nguyen's role at San Francisco Clinical Research Center?

Tony Nguyen is Clinical Research Coordinator

What is Tony Nguyen's personal email address?

Tony Nguyen's personal email address is o****[email protected]

What is Tony Nguyen's business email address?

Tony Nguyen's business email addresses are not available

What is Tony Nguyen's Phone Number?

Tony Nguyen's phone (213) ***-*708

What industry does Tony Nguyen work in?

Tony Nguyen works in the Biotechnology industry.

Who are Tony Nguyen's colleagues?

Tony Nguyen's colleagues are Neda Ronaghi, Jack Zhao, Robert Shortt, Cody Williams, Qinwen Liu, Meredith MD, Susan Tang, Suhyoun Han, Brian Bentson, and Qi Mo

About Tony Nguyen

📖 Summary

Clinical Research Coordinator @ San Francisco Clinical Research Center From October 2009 to March 2010 (6 months) Manager- Clinical Systems and Records Management @ Ultragenyx Pharmaceutical Inc. From April 2016 to August 2017 (1 year 5 months) San Francisco Bay AreaAssociate Director - Clinical Documentation @ Nektar Therapeutics San Francisco, California, United StatesSenior Manager Clinical Compliance -TMF and Ancillary Systems @ GRAIL, Inc. From April 2018 to March 2020 (2 years) Menlo Park, CaliforniaSenior Manager- Clinical Systems and Records Management @ Ultragenyx Pharmaceutical Inc. - Lead cross-functional teams through planning, design, configuration and deployment of new clinical systems and enhancements to existing applications. Includes coordinating and participating in system requirements, development, user acceptance testing and system enhancements- Partner with IT, Quality Systems, QA, and Clinical Operations stakeholders on all clinical system integrations, enhancements, and upgrades. - Support the Clinical Operations team in managing the CTMS, eTMF, and IRT vendor relationship on a day-to-day basis to ensure optimum system performance and to address/escalate issues, as appropriate.- Develop Standard Operating Procedures (SOPs) and guidelines related to the management and use of clinical systems as well as development of SOPs for establishment, maintenance, and archival of the TMF. - Provide training on CTMS, eTMF, IRT, and other clinical systems- Act as a change agent to ensure minimal organizational disruption during new system/process implementation- Support administration activities of clinical systems (e.g., User Management, configuration changes, etc). - Partner with internal teams to analyze clinical systems and vendor performance to ensure compliance against contracted services.- Support end users as an internal clinical systems (eTMF, CTMS, and IRT) Subject Matter Expert. - Oversee governance for eTMF, CTMS, and IRT/IxRS clinical systems- Partner with senior management to develop a clinical systems strategy for Clinical Operations.- Evaluate new technologies- Manage Records Management (4) and TMF SWAT Team (3)- Support Inspection Readiness activities- Act as TMF/Records Management Subject Matter Expert during regulatory inspections. From September 2017 to April 2018 (8 months) San Francisco Bay AreaProject Manager @ Bracket Project Manager (March 2015- April 2016)Associate Project Manager (September 2013- March 2015)Senior Project Specialist (December 2012- September 2013)• Manage project activities to ensure the timely and quality preparation of project deliverables basedon assigned scope-of-services, e.g. cognition services, EDC/IxRS maintenance study, etc.• Ensure all project deliverables are of high quality and exceed client’s expectations, in conjunctionwith QA• Liaise with clients regarding project activities including status communication and project deliverables• Oversee management of study site personnel including all internal and external communication• Coordinate cross-function, e.g. Technical Delivery, Total Quality Management, Clinical, Translations, Data Management, etc., project activities to ensure relevant deliverables are delivered on-time, within budget and of high quality.• Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams• Own in-study/maintenance transactional project activities throughout entire project lifecycle, e.g.project variable fees, inter-department workflow assignment, issue escalation• Design and configure unique project systems and manage data for each assigned project, utilizingproprietary IT applications (e.g. RDA, IR2, CDR PRISM, etc.)• Oversee project QC activities to ensure compliance within the enterprise Total Quality Management System• Leverage Project Assistant pool resources to effectively complete project maintenance tasks -manage Sr. Project Assistants and/or Project Assistants as assigned From December 2012 to April 2016 (3 years 5 months) San Francisco Bay AreaClinical Research Associate @ Sutter Health- California Pacific Medical Center Clinical Research Associate (December 2011-December 2012)- Directed a NIH funded project for Non Alcoholic Fatty Liver from study initiation, IRB documentation, and grant renewals.- Oversaw best practices in research of MRI replacement techniques specific to liver biopsy in an attempt to modernize the approach for diagnosing liver disease, thus reducing the risk of infection and complications- Contributed as co-author to three scientific abstracts/journalsClinical Research Coordinator (March 2010- December 2011) From March 2010 to December 2012 (2 years 10 months) Clinical Research Coordinator @ Southern California Institute for Respiratory Diseases • Initiated Phase 1 Clinical Trial for Alexza Pharmaceutical's Chronic Obstructive Pulmonary Disease (COPD) investigational drug AZ-004CO• Created and implemented new standard operating procedures (SOP's) that adhere to Good Clinical Practice (GCP), International Conference on Harmonisation (ICH), and Health Insurance Portability and Accountability Act (HIPAA)• Constructed a SQL database for site to use as a recruitment tool to pre-screen and identify subjects From May 2009 to September 2009 (5 months) Los AngelesClinical Research Coordinator @ Osteoporosis Medical Center - Implemented six clinical studies (Phase II-Phase IV) focusing on indications such as osteoporosis, osteoarthritis, and fibromyalgia for Novartis, Lilly, Jazz, GlaxoSmithKline, and Siemens using GCP/ICH standards- Initiated various recruitment strategies to enroll patients for our clinical trials that resulted in the recruitment of 100 patients- Managed six clinical studies while co-authoring and conducting statistical analysis on a research paper regarding male osteoporosis validating a quality of life tool that was published with Osteoporosis International in April 2012. From June 2007 to September 2009 (2 years 4 months) Beverly Hills, CA

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In a nutshell

Tony Nguyen's Personality Type

Extraversion (E), Intuition (N), Thinking (T), Perceiving (P)

Average Tenure

1 year(s), 8 month(s)

Tony Nguyen's Willingness to Change Jobs



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