Project Manager Management

Vincent Gu

Clinical Trail Management, Trial Master File and Regulatory Document Management, Clinical Data

Review

*********.******@*****.***

Summary

Collaborative Professional experienced in providing oversight and support for domestic and international

clinical trials from site selection through enrollment, information management, and completion. Offer combined

background of 10+ years in pharmaceutical industry, including clinical trial management abilities. Excel at

coordinating and communicating with various internal/external groups for timely completion while focusing on

quality and overall objectives. Thrive in fast-paced environments; apply keen problem-solving, analytical, and

technical/computer skills.

Experience

Clinical Trial Assistant at Forest Laboratories

March 2007 - April 2014 (7 years 2 months)

Contributed to clinical trial management for Phase III & IV clinical studies in cardiovascular therapeutic area.

Provided oversight for multiple study sites and addressed protocol-specific inquiries related to study

procedures and subject eligibilities. Involved in weekly clinical study team meetings and prepared meeting

minutes/agenda. Maintained communication with sites to collect updated weekly patient enrollment numbers

along with address site issues and enrollment challenges. Participated in determining study budget

requirements per patient cost.

Clinical Documentation Specialist II at (OSI) EYETECH PHARMACEUTICAL

July 2006 - February 2007 (8 months)

Managed regulatory document control systems and processes for two corporate locations in accordance with

site and corporate cGMPs, safety, environment, and HR policies and procedures. Modified master SOPs and

provided file, status, and technical reports. Handled document database updates, maintenance, and user

training.

Clinical Documentation Associate at IRIS, INC.

March 2005 - June 2006 (1 year 4 months)

Performed document collection, preparation, scanning, indexing, discrepancy management, and archiving for

customers of technical/document solution management company.

Assistant IT Project Manager at STEVE & BARRY’S UNIVERSITY SPORTSWEAR, INC.

October 2004 - January 2005 (4 months)

Supported project manager in application design and maintenance as well as provided resolution for IT help

tickets and internal helpdesk requests, including operating system installations and hardware/software

troubleshooting.

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Case Report Form Developer at Pfizer

June 1999 - October 2003 (4 years 5 months)

Produced CRFs using optical/intelligence character recognition automated data capture technology for

electronic document repository (Cardiff TeleForm 7.0). Interfaced with clinical operations team to determine

form design and specifications. Generated study status reports using Access and created weekly SQL-driven

reports for management review. Developed CRF modules and templates for upload into TeleForm library.

Education

Columbia University in the City of New York

Certificate, Health Information Technology - Data Exchange Specialist, 2012 - 2013

State University of New York College at Old Westbury

Bachelor's Degree, Management Information Systems, General, 2000 - 2002

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Vincent Gu

Clinical Trail Management, Trial Master File and Regulatory Document Management, Clinical Data

Review

*********.******@*****.***

Contact Vincent on LinkedIn

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Contact this candidate