Data Entry Manager

DAVID LEE

** ******** **** **** ****: 908-***-****

Belle Mead, NJ 08502 Cell: 908-***-****

www.linkedin.com/in/davidlee08502 *********@*****.***

PROFESSIONAL SUMMARY

Results-oriented executive with fifteen years of high-tech experience in business development and strategy. Able to clarify issues, advocate solutions, mobilize cross-functional support, and facilitate decision making in complex situations. Proven ability to develop and implement measurable and profitable programs in a cost-conscious environment. A well-respected and dedicated professional, capable of motivating a cross-functional team to produce quality work.

AREAS OF EXPERTISE

Design/Develop Data Programs

Analyze/Test/Validate Data Programs

Stakeholder Collaborations

Team Leader

Clinical Trial Metrics Programming

Statistics Programming

Advanced SAS

Oracle Clinical

PL/SQL Languages

BUSINESS EXPERIENCE

NOVO NORDISK, INC, Princeton, NJ 1999 – Present

Novo Nordisk is the leading provider of diabetes-care products in the world and manufactures and markets a variety of human and modern insulin products as well as oral anti-diabetic agents. Novo Nordisk markets its products in 180 countries worldwide.

Principal Clinical Data Analyst (2011 – Present)

Responsible for coordination/communication, administration, and personnel development to ensure compliance with the application and communication of all Novo Nordisk policies, procedures, and fundamentals. Act as primary Data Manager for assigned studies to convey project information, answer questions and report to study group (including International Study Group meetings) during trial conduct and closure phases. Ensures that mandatory Data Management trial documents are filed in NovoDOCs or trial master files.

Established and implemented the staggered Database Lock initiatives which led to achieve the global Database Lock for the SUSTAIN-6 trial one week before the planned target.

Built and maintained good relationships with key stakeholders resulting in excellent collaborations and team work which made the achievement of major milestones smooth and well executed.

Lead Clinical Database Analyst (2006 – 2011)

Responsible for review protocols and resolving lab issues, managing the relations with clinicians, statisticians, data quality, statistical programmers, and site management. coordinated external data sources, including temporary employees and CRO. Coordinated the design and setup of database for studies. Assured consistency across trials. Directed the development of data entry screens, data entry requirements, and case report forms.

Participated in clinical trials which successfully met and exceeded the data management targets and metrics set forth in the performance plan.

Demonstrated progress on leadership competencies, became more visible in study teams, obtained relevant information, and assisted in decision-making.

Created various Oracle Clinical derivation procedures to meet the OC change requirements avoiding the EDC vendor’s change orders which led to saving time and resource costs.

Senior Clinical Database Analyst (2002 – 2006)

Responsible for setup of database and test database for assigned trials using Oracle Clinical. Loaded laboratory data and handled discrepancy for lab data. Developed and coded validation programs in accordance with the validation rules.

Ran monthly tracking report for additional trial simultaneously to assigned trials.

Wrote scripts and created Oracle Clinical back-end listings and reports, completed patient listings, and communicated to key stakeholders on time.

Communicated extra protocol deviations found during data cleaning or other significant data quality issues to trial team.

DAVID LEE PAGE 2

Clinical Database Analyst (1999 – 2002)

Responsible for setup of databases, panels, code lists, and entry forms using Clintrial. Developed edit checks and implemented validation programs using PL/SQL languages. Created processes and programs to automate the generation of CRF query form.

Created ad hoc reports in addition to standard reports for project manager, international trial manager, clinician, and other stakeholders resulting in shortened discrepancy review days.

Created listings capturing the last known insulin doses for all randomized subjects.

ORGANON PHARMACEUTICALS USA, INC., West Orange, NJ 1998 – 1999

Organon Pharmaceuticals USA, Inc. engages in developing and producing prescription medicines for gynecology, psychiatry, cardiovascular disease, immunology, and anesthesia. The company is based in Roseland, New Jersey. Organon Pharmaceuticals USA, Inc. operates as a subsidiary of Merck & Co. Inc.

Statistical Programmer

Responsible for creation of tables, figures, and listings of statistical results, using SAS Procs Tabulate or Report, Data Null Step, and SAS/GRAPH. Responsible for producing graphics and tables (CGM, RTF, and PDF files) for medical writers.

Handled requests going above and beyond line of duty, and never missed a deadline.

Ensured that deliverables were completed on time and frequently ahead of the agreed deadlines.

Developed an automated system to convert SAS output file to Microsoft Word document file.

ACRO CONTRACT RESEARCH ORGANIZATION, INC., Morris Plains, NJ 1995 – 1998

Consultant

Developed, tested, and validated data entry system for a major international drug manufacturer.

Designed CRF forms and tables using PowerBuilder, Sybase, and Oracle.

Developed and implemented SAS programs for analyzing and reporting the results of clinical trials for multiple NDAs, CRF tabulations, laboratory analysis, and data listings.

Developed an automated system to convert SAS output file to Microsoft Word document file.

EDUCATION

M.S., Computer Science, The University of Texas at El Paso, El Paso, TX

B.A., Major: Education; Minor: Mathematics, National Taiwan Normal University, Taipei, Taiwan

PROFESSIONAL DEVELOPMENT

SDTM Theory & Application – CDISC

InForm ITM 4.5 Reporting and Analysis – Phase Forward

Oracle Clinical Normlab2 Training Program - Novo Nordisk A/S

Oracle Clinical Training Session

Validating Clinical Data Management Annual Conference

SAS Advanced Programming Techniques & Efficiencies

SAS Macro Language

Data Warehousing Overview: Theory and Business Concepts

SELECTED AWARDS & RECOGNITIONS

Assisting Data Quality Group with Study NN9535-3744 – Novo Nordisk Inc.

Outstanding Hard work on the VAG-2195 Trial - Novo Nordisk Inc.

Changing the Course for GOOD - Novo Nordisk Inc.

SELECTED COMMUNITY AFFILIATIONS

Church Elder, TAFPC, New Brunswick, NJ

Commissioner, Presbytery of New Brunswick, NJ

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