Work History

Work History
2010 - 2012

Business Analyst (contract)


Medicines Development Group, Applications and Data Integration• Developed tools and processes to extract and copy clinical data files from various systems for integration processing using Visual Basic for Applications (VBA), Documentum Query Language (DQL), and Robocopy. • Evaluated clinical study data files and study design from over 500 protocols for integration into new data systems. • Worked with business owners and delivery workstreams to develop optimal solutions. • Developed complete and accurate business models including process, data, and organization as required. • Worked with business owners from affected business areas to understand current processes and to document and prioritize requirements. • Worked with delivery workstreams to communicate business objectives and requirements, make decisions on delivery options and produce delivery costs and timescales. • Worked with project managers to plan analysis work and highlight risks and issues. • Worked with the business owners to define acceptance criteria. • Developed User Acceptance test plans and business models incorporating process and data models. 

• Wrote test scripts for laptop migration. • Provide input into Project Manager’s weekly reports on progress against milestones, status, resource requirements, issues, risks, and dependencies. • Created and executed project work plans and revise as appropriate. • Created weekly project manager’s reports on progress against milestones, status, resource requirements, issues, risks, and dependencies.

2007 - 2009

Business Analyst

LabVantage Solutions

Business Analyst – Professional Services Organization (PSO)

Interfaced with subject matter experts (SMEs), and other project stakeholders, to understand user business processes to increase efficiency and ease transition to new scientific applications.Gathered functional requirements, wrote functional specifications, and monitored development and configuration of customized Laboratory Information Management System (LIMS) systems.

• Conducted customer site audits with lab scientists and SMEs for information gathering.

• Prepared functional and technical documentation, and testing and acceptance plans.

• Outlined design models for Sapphire databases.Collaborated with Solutions Engineers to implement and develop customer solutions.

2002 - 2007

LIMS Manager

Wyeth Research (now Pfizer)

LIMS Manager – Systems Support Group, Bioanalytical Research (BA),

Drug Safety & Metabolism division (DSM)

WATSON LIMS Manager (DBA) for BA, Pearl River site

Provided support for all system functions to scientific and other users in BA, Pearl River, and other sites and related groups as needed.Trained new users and performed update training.

• Gathered user requirements and created specifications for new system functionalities during vendor development, then worked with vendor developers to evaluate solutions.Supported application development, validation, and implementation.

• Liaised between lab/scientific staff and IS/IT groups.

• Managed various department databases, department IT inventory and purchasing.

• Part 11 Project Manager for entire Drug Safety & Metabolism division (DSM).

Clinical Data Manager for BA department interactions with Clinical Department.

• Evaluated Clinical Department procedures, programmed and implemented application and automated process to transfer clinical trial data to CROs, and internal and external labs, eliminating manual processing and errors, and reducing processing time over 95%.

• Created automated processes to streamline transferring study data back to Oracle Clinical from various internal and external lab systems.

1999 - 2002

QA-IS Specialist

Wyeth-Lederle Vaccines (now Pfizer)

QA-IS Specialist – Biological QA Department

2001 - 2002

Project Manager for migrating WLV Pearl River site from paper-based SOP system to GxPharma (Documentum) EDMS

•Interviewed, hired, and managed staff of seven to assist in project completion.

•Created project plan and budget.

QCIS Coordinator – Biological QA Department

1999 - 2001

Managed QCIS LIMS system to ensure proper collection, calculation, and analysis of Quality Control test data used to support product release in a GMP environment.

•Provided support for all system functions to users in Pearl River WLV.

•Interfaced with QC laboratories and QA personnel to generate QCIS test proceduresand specification limits.

•Maintained test procedure paper and electronic files.

•Trained end users.

1992 - 1999


Wyeth-Ayerst Research (now Pfizer)

Scientist – Drug Safety & Metabolism

Performed various procedures for the determination of drug distribution, metabolite identification, and drug levels, in a GLP environment for Pre-Clinical and Clinical studies.

•Assisted in experimental design and set up, data reduction, and analysis.

•Created various applications to automate report writing.

1991 - 1992

Research Assistant

The R.W. Johnson Pharmaceutical Research Institute, Ortho Pharmaceuticals Corp. (J&J)

Research Assistant – Drug Metabolism Department

Performed drug level analyses in various Clinical Studies

•Validation of Radioimmunoassays on human biological fluids




Mercer County Community College

Coursework:Clinical Data Management;Clinical Research Coordinator/Clinical Research Associate (CRC/CRA);Privacy and Data Protection for Healthcare and Pharma;Regulatory Affairs and Legal Issues in Drug Development;Foundations of Clinical Research and Study Design


Mini-MBA Certificate

Rutgers, The State University of New Jersey-New Brunswick

Professional Certificate

DeVry Institute


Rutgers, The State University of New Jersey-New Brunswick

Minor in Music


Laboratory IT systems and applications manager, adept at facilitating communication and collaboration between scientific/lab personnel and IS/IT groups.

• Strengths include: understanding regulated (GxP) laboratory needs, problem solving, relational databases, and diverse computer systems and software tools.

• Ability to understand and liaise with scientific staff and other subject matter experts to initiate application development, implementation, and use.

• Experienced in increasing efficiencies by developing data processes/systems, and delegating tasks to other support staff while managing projects.

• Extensive laboratory knowledge, as both a scientist and in applications support.


Drug Development & Clinical Research Coursework:

Clinical Data Management;Clinical Research Coordinator/Clinical Research Associate (CRC/CRA);Privacy and Data Protection for Healthcare and Pharma;Regulatory Affairs and Legal Issues in Drug Development;

Foundations of Clinical Research and Study Design, Mercer County Community College

Computer Skills:

Proficiency in various computer systems and software packages, including:

Sapphire, WATSON, NuGenesis SDMS Admin, Softmax Pro, Totalchrom, ChemLIMS, BRIO, Crystal Reports, UNIX, MS DOS, C, Visual Basic, VBA, PowerBuilder, SQL, MS Project, Access, Word, Excel, Powerpoint, SigmaPlot, SharePoint, eRoom

Computer Systems Training:

Presenting Data and Information, Edward Tufte

NuGenesis SDMS Administration, Waters Corp.

A Practical Approach to Compliance with 21 CFR Part 11, Taratec Development Corp.

Computer Systems Validation, Taratec Development Corp.

Brio Explorer/ Designer/ Custom Application for Designers, Idea Integration

Fundamentals of the UNIX System, HP Educational Services

Computer Systems Coursework:

Programming Concepts with Visual Basic (with Lab), DeVry

Operating Systems & Networking Theory (including UNIX) (with Lab), DeVry

Database Management Systems (including SQL & Access) (with Lab), DeVry

Client Server Systems - PowerBuilder (with Lab), DeVry

Programming with C (with Lab), DeVry; Advanced Programming with C (with Lab), DeVry

Scientific Skills/ Equipment:

HPLC (UV, EC, Fluorescence, and RadioDetection), Rapid Trace, GCMS, RIA, Solid Phase Extraction, TLC, Microscopic Techniques, Liquid Scintillation Counter

Scientific Coursework:

Biochemistry, Microbiology, Oncology, Radiation Biology, Genetics, Immunology, Cell Physiology, Systems Physiology, Disease in History, Animal Social Behavior, Independent Research in Biology