Summary

I have been working in health care and pharmaceutical companies for more than 25 years. I worked at IT for the first 10 years as a software developer to support clinical trial development in preclinical and clinical areas. Then year 2001 I took a manager position to manage different teams of Clinical Data Technology and Clinical System development professionals to provide skills and knowledges to translate clinical trial protocols into an electronic data capture system in support of clinical database set up, data collection, data query, and data reporting. Both Pharmaceutical and CRO’s experiences allow me to see different business needs, and I have gained lots of hands on experiences in clinical data standards implementation, process enhancement, project management, day to day operational support, and cross functional communications. I like this industrial and would like to look for a position that I can continue to use my experiences. I have a B.S degree in computer engineering, a M.S degree in computer science, and a M.S.degree in bioengineering.

Work History

Company: PRA Health Sciences, Deerfield, IL (Acquired from Takeda)

Title: AD Clinical Data Tech

Dates: October 2016 – March 2020

Responsibilities

and accomplishments:

Leads a group of PRA partnership colleagues supporting all Takeda studies at CDM PRA Takeda embedded business unit

Manages the CDTA (Clinical Data Technology Analysts, from Takeda) function to transition to PRA company

Manages a team with 5 clinical system designers and 3 clinical system developers to develop clinical trials in EDC (build off protocol, build EDC databases, generate reports and listings)

Manages project timelines, task assignments for many sponsors’ clinical projects

As a representative from clinical system development function, works with Account Groups (sponsors and vendors) to maintain PRA and client’s relationship (more than 30 clients), monitor risks and help to investigate root causes

Manages PRA’s compliances (trainings and standards)

Conducts RFPs review as a representative of CSD (clinical system development function) for many clients’ new projects

Leads on projects to improve cross functional operations and communications

Works with other management team members to develop process enhancement

Works with other management team members to enhance and employ a new system supporting day to day operations

Maintains management responsibilities including recruitment, orientation, retention, evaluation and career development.

Company: Takeda, Deerfield, IL January 2001 – September 2016

Title: AD Clinical Data Tech

Dates: August 2015 – September 2016

Responsibilities

and accomplishments:

Sets Clinical Data Technology strategy and direction for Clinical Data Management and Technology, including feasibility assessments for new technologies, new tools and functionality of current tools.

Manages team of Clinical Data Technology professionals to provide electronic data capture (EDC) and data standardization expertise in support of global, development projects and marketed products.

Defines, leads and implements global strategies for clinical data technology resourcing, standards, processes, and systems to maximize efficiency and global data integrability.

Partners with Information Technology to provide inputs and testing application of tools for Clinical Data Technology group

Independently represents Takeda clinical data technology function in external professional initiatives, organizations and forums, such as CDISC, and PhUse user group Groups, etc.

Ensures compliance of function with Takeda SOPs, standards, and all applicable regulations.

As a CDMT function representative to review all relevant SOPs provided by quality management system

As an owner of Takeda’s CRF standards and global data library, review and process all the updates and user requests

As a part of Takeda's harmonized standards working team, attended all the discussions of developing new domains

Title: Sr. Manager, Clinical Data Technology

Dates: December 2014 – July 2015

Responsibilities

and accomplishments:

Contributes to Clinical Data Technology strategy and direction for Clinical Data management and Technology, including feasibility assessments for new technologies, new tool and functionality of current tools

Acts as liaison with cross functional areas to set direction and define requirements of systems/tools and oversee the implementation of system, utilities and standards required to support project work

Provides expertise in the implementation of global strategies for clinical data technology resourcing, standards, processes, and systems to maximize efficiency and global data integrability

Manages team of Clinical Data Technology professionals to provide electronic data capture (EDC) and data standardization expertise in support of global development projects and marketed products

Maximizes effectiveness and efficiency in use of internal and external (CRO) technology resources

Performs management responsibilities including recruitment, orientation, retention, evaluation and career development.

Supports achievement of major development program milestones in coordination with other functions including Statistics, Data Management, Clinical Operations and Pharmacovigilance

Ensures compliance of function with Takeda SOPs, standards, and all applicable

lead the effort to build an operational process that CDTA group can follow for both EDC builder and backend programming tasks, processes describes steps of working with TOP CROs

As an owner of Takeda's CRF standards and global data library, review and processes all the updates and user requests.

led a working group to evaluate eSource technology and feasibility for Takeda to use

Title: Sr. Manager, Clinical Data Standard Management

Dates: July 2010- November 2014

Responsibilities

and accomplishments:

In collaboration with the Directors and managers of Clinical Study Standards Strategy and Clinical Data Integrity and Technology functions, establishes and drives implementation of global Analytical Science strategy on standards, processes and technologies related to clinical study data collection and analysis.

Continue to monitor relevant industry best practices and regulatory developments, evaluate and suggest to Analytical Science management with recommendations on strategies and plan for implementation of new standards, technologies, tools and processes.

Manages the group of clinical data standards management staffs and leads activities within the group.

An owner of both Takeda CRF standards specifications and tabulation datasets specifications. Leads cross functions and cross regions working groups for maintenance and revision of these specifications. Ensures the proper implementation of standards, processes, and tools by Analytical Science department. Serves as SME for supporting general standards and process questions.

Represents Analytical Science department in US, in collaboration with Japan and Europe, to drive strategy, development, and implementation of standards and processes.

Represents standards function, is a member of Takeda Lab Governance committee work with Clinical operation and Takeda’s preferred lab vendors to improve and manage lab data quality and process

Manages internal standards library and oversight vendor for utilization of Takeda standards.

Developed a Takeda's SDTM standards and ran a pilot study

Finished a 3 months secondment assignment in Japan. Learned Takeda Japan's processes

A three years of PhUSE member

Leads and manages the CDISC project to develop a Takeda CDISC-based system. Successfully finished CDISC assessment, CDISC FCC project, and CDISC pilot study

Title: Sr. Manager, Data Management Programming

Dates: April 2006 – June 2010

Responsibilities

and accomplishments:

Leads and manages the global (US/EU) Data Management programming function to provide data management programming expertise in support of global development projects and marketed products

Oversees all data management programming activities to ensure compliance of data standards and provide access to data capture and data query tools for all clinical studies led from the US or EU

Defines resource requirements, priorities and staffing assignments across US and EU led projects. Performs management responsibilities for recruitment, orientation, retention, evaluation and career development of Data Management programming group members

Supports achievement of major development program milestones in coordination with other functions

Provides functional direction for evaluation, selection and management of external technology vendors

Defines and implements global strategies for data management programming resourcing, standards, processes, and systems to maximize efficiency and global data integrability

Title: Manager. Database Programming

Dates: January 2001- March 2006

Responsibilities

and accomplishments:

Manages the development and design of databases for TGRD/US in-house clinical trials processed in Oracle Clinical System

Interfaces with DMs, Programming, STATs, IT CDMS group, TCI Data Management, TCI IT, and external provider

Represent sTGRD/US Database Global Liberian in managing standards in Oracle Clinical System

Participates the development of Standard Database (SDB) and ensure SAS datasets compliance

Manages and define the specifications of electronic data from external resources

Develops tools and reports to support clinical trials

Leads the EDC project team to assess broader implementation of EDO in TGRD/US

Represents Takeda in CDISC initiatives to follow up with CDISC’s development

Develops and maintain a staffing strategy to ensure resources are allocated to all projects

Develops working instructions for Database programming groups functions in conjunction with the BDMs standard operating procedures

Develops standard operating procedures (SOPs) for Data Management activities

Company: Pharmacia, Skokie, IL

Title: Sr. Application System Analyst Programming

Dates: July 1997- Jan 2001

Responsibilities

and accomplishments:

Develops and Deploy several systems to support the Clinical Data Management

Performs application validation processes including creating validation protocol, creating test scripts, executing validation tests, and writing validation report.

Designs a Electronic CRF Tracking System (database, user interfaces, and reports) from user initial requirements and system specifications to final

Company: Searle, Skokie, IL

Title: Sr. Application System Analyst Programming (support pre-clinical)

Date: July 1992 - June 1997

Responsibilities

and accomplishments:

Provides Oracle database programming and application design to support Pre Clinical Research and Development

Performs application validation processes including creating validation protocol, creating test scripts, executing validation tests, and writing validation report

Designs the validated system, Clinical Pathology Workstation System

Company: University of Illinois at Chicago, Chicago, IL

Title: Senior Research Specialist

Date: September 1987 – June 1992

Responsibilities: Develops many programs to support scientific research in sleep disorder lab

Education

Graduate, MS in BioEngineering, May 1993

University of Illinois at Chicago, Chicago, IL

Graduate, MS Computer Science, May 1987

Old Dominion University, Norfolk, VA

Undergraduate, Computer Engineering, Feb 1982

National University of Defense Technology, ChangSha, Hunan, CHINA

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