· 25+ years’ experience in Business Analysis, Process Engineering, Data Architecture, Requirements Specification, Computer System Validation and 21 CFR Part 11
· Experience includes the identification, documentation, and implementation of Process Improvements in IT organizations (including FDA regulated environments)
· Full Software Development Life Cycle (SDLC) experience, from exploration, scoping and planning through construction, roll-out, maintenance through change management, post-implementation review and system retirement
· Track record in developing and maintaining Project Plans, Project Documentation, tracking/reporting progress to steering committees and preparing/delivering presentations to executive committees
· Strong people skills; working with the team as an insider to build consensus and buy-in
General: Business process analysis and engineering; logical system architecture; enterprise and application modeling; needs assessment, requirements gathering and specification; project planning, tracking and control; methodology authoring and customization; quality assurance standards and reviews; technical writing, documentation and user manuals
Environments: Client-Server, PC (NT, 2000, XP), Mainframe
Methodologies: Information Engineering, Zachman framework, Rational (RUP), Business Process Re-engineering (BPR), Kimball
Software: CASE tools (ERwin, Proforma, Casewise), Unified Modeling Language (UML), Microsoft Office, Project, Visio
EDUCATION
MS, Computer Science - Polytechnic University
MBA, Information Systems / Management Science - Iona College
BS, Psychology and Mathematical Statistics – Columbia University
Columbia University Medical Center November 2007 to March 2008 (New York, NY)
Business Systems Analyst
Led the design of live data interfaces for enterprise-wide implementation of a clinical trials management system (Velos eResearch) integrating university research with hospital patient care. Identified authoritative data sources; specified business rules for data feeds utilizing HL7 protocol. Authored technical specifications for future data feeds; analyzed, documented workflow changes. Produced future state use cases, data flow diagrams and process maps using Visio.
Atlantic & Pacific Tea Company (A&P) September 2007 to October 2007 (Montvale, NJ)
Business Analyst
Conducted facilitated workshops with SMEs to elicit AS IS process maps prior to migration of legacy cost data off mainframe onto open Unix platform / Oracle financials. Developed client relationship interaction diagrams, and storyboarded high level business processes. Conducted AS IS / TO BE gap analysis, designed use cases, and defined standard roles. Re-engineered the design of role-based TO BE process workflows for cost data maintenance using Visio. Assessed staff’s ability to adopt new practices; evaluated comparative AS IS / TO BE work efforts.
MetLife Long Term Care May 2006 to September 2007 (Westport, CT)
Business Analyst
As consultant for a systems integration solutions provider to an insurance carrier offering long term care (LTC) health insurance products, conducted assessment of back office operations. Produced maps of process flows (current state) using Visio. Identified and analyzed controls, quality factors and management checkpoints. Captured business rules and system rules. Performed data analysis including status code normalization. Produced models of current state data flows, and evaluated the impact of business decisions on funding reserves. Recommended opportunities for process re-engineering.
Moody’s Investor Services December 2005 to April 2006 (New York, NY)
Technical Writer / Business Analyst
As documentalist for an IT solutions provider employing the RUP methodology, wrote and maintained all documentation for the project including the statement of work (SOW), project plans, business requirements document (BRD), glossary of terms, use cases (UC) document, technical standards and templates for a Microsoft .Net architecture and framework. Edited, standardized, and revised legacy documentation prepared by other writers and technical personnel. Brought sub-par existing documentation to high production standards required by demanding client. Organized disparate project information artifacts (e.g., working papers). Maintained a repository of project documents in SourceSafe. Authored the project’s business domain model (BDM) using Visio.
Idea Integration / News
Business Analyst / Technical Writer
As consultant for a systems integration solution provider to a media sales firm, analyzed the client’s system platform with the goal of re-writing the entire suite of legacy applications. Participated in formal business requirements gathering workshops, and produced the logical models (including narratives) for current state and future state (i.e., re-engineered) process flows using Visio.
Princetec, Inc. November 2004 to June 2005 (Princeton, NJ)
Technical Writer / Documentalist
For a start-up software company, wrote a full-featured User Guide intended for distribution with their web-based proprietary software product that supports business customers in maintaining legal contracts.
Utilizing screen shots and source documents, defined use cases and developed screen flow diagrams to demonstrate how a typical user might navigate the application interface and access the database. Authored the Guide to support the use cases and follow the screen navigation flows. Accessed the test version of the system to simulate a typical user and validate the Guide. Maintained the Guide in parallel with planned future releases of the application.
Pfizer Global R & D October 2003 to October 2004 (Groton & New London, CT)
Project Start-Up / Requirements Definition and Prototype Development
Defined the scope and requirements for two high-priority projects to develop information management systems to support the needs of chemists operating in the regulated environment. Planned the projects, gathered requirements, scoped and defined the products, and participated in the design of the applications. Conducted interviews with over twenty subject matter experts, led workshops, analyzed user processes, constructed logical models using Casewise Corporate Modeler, ERwin and Visio, defined requirements, developed prototypes, facilitated user / stakeholder playback sessions, wrote project documents, and reported to steering committees. Work products for each project included: project plans, context diagrams, user department workflow process models (both “as is” and “to be”), life cycle analysis, data flow models, use case models, logical data models, requirements documents, paper prototypes, logical product designs and program module functions, specifications and algorithms.
Directed the effort to build pilot versions of the applications. Coordinated the IT/client relationship. Led teams of 3 developers and data analyst in the implementation of two working prototypes. Wrote user acceptance test plans, guided user acceptance testing and program revision procedures.
Covance, Inc. January 2003 to August 2003 (Princeton, NJ)
Systems Development Methodologist and Process Re-Engineering
For a professional services firm that specializes in clinical trials to the pharmaceutical industry, evaluated the client's system development life cycle (SDLC) processes for compliance with FDA-mandated computer systems validation (CSV) guidances. Interviewed subject matter experts, documented current practices, built "as is" process models using Proforma and Visio, and conducted workshops to walk-through and validate the models. Produced "to be" process models using Proforma and Visio as the basis for re-engineering of the SDLC methodology and remediation of SOPs.
Authored a RUP-based, template-driven methodology for client’s clinical IT function to guide software development projects from exploration and planning through construction, roll-out, change control / change management (including revisions to computer programs), retirement and post-implementation review of systems. Incorporated industry best practices into the SDLC methodology; integrated CSV (Validation) principles, tasks and documents into the methodology. Wrote new SOPs for re-engineered SDLC and Validation processes.
Authored a comprehensive User Guide for the SDLC methodology; trained business users and IT users in the utilization / deployment of the methodology for the SDLC and Validation processes.
Merck Research Laboratories September 2002 to December 2002 (Rahway, NJ)
Business Analyst / Quality Assurance
Specializing in documentation clean-up for a pharmaceutical research organization, remediated existing system documentation to bring it into compliance with FDA validation regulations, adhering to company’s standard operating procedures (SOPs).
Conducted needs assessment, defined user requirements and re-wrote the functional requirements specification (FRS) and system design specification (SDS) for the clinical trials data management application, utilizing these techniques:
- reverse engineered high-level requirements from existing application, documentation, test scripts
- used VisualMind (mind mapping) to build logical models (function decomposition and use-cases)
- brainstormed with current application developers and testers to discover missing requirements
- wrote new requirements using a templated requirements formatting tool
Pfizer Global Research & Development August 2001 to August 2002 (Groton, CT)
Business Analyst / Requirements Definition
Conducted interviews with over fifty subject matter experts (including laboratory scientists, manufacturing engineers and executives). Conducted brainstorming sessions and needs assessment, gathered and defined requirements, constructed logical models according to RUP guidelines, developed use cases, facilitated user / stakeholder playback sessions, wrote fully validated requirements documents and designed user acceptance testing for:
- the Materials Assessment Laboratory (substance physical properties database)
- IntelliChem’s Synthesis (chemistry recipes and pilot manufacturing scale-ups)
- Metrology Equipment Tracking (preventive / corrective maintenance tracking & IQ/OQ/PQ)
- Quality Assurance Data Base (audits & investigations contact management)
Logical models developed for each project included use cases, life-cycle state transitions, process flows and data models. Final requirements document specified user requirements, system requirements, program functions / algorithms, regulatory requirements, best practices (GMP and GLP), FDA validation and 21 CFR Part 11 requirements. Developed user acceptance testing (UAT) designs, including test procedures and scripts. Guided UAT testing.
Loan Pricing Corp. April 2001 to July 2001 (New York City)
Project Start-Up / Process Improvement
For a vendor in the commercial loan marketplace, developed a Zachman-based SDLC methodology. Specified modeling techniques for the enterprise-wide re-engineering of the company's processes and re-architecting of the company's data resources. Provided project direction, leadership in an unstructured start-up situation. Conducted needs assessment; defined content, scope and boundaries of the project.
Identified and defined project deliverables. Developed the initial project plan, designed user acceptance testing strategy and gave presentations to executives, IT management and operations personnel.
Trained and mentored a small team of subject matter experts in the practice of logical modeling. Documented the "as is" business processes and analyzed current operations for process re-engineering opportunities. Aligned systems architecture to long-term business strategy.
Scholastic, Inc. March 2000 to August 2000, & September 2000 to March 2001 (Secaucus, NJ)
Process Modeling / Data Modeling
For a supply chain re-engineering and integration effort, conducted a needs assessment and developed a suite of process models representing the demand forecasting function. Aligned system architecture to business strategy. Built models for the "as is" and "to be" business processes linked to the enterprise data model. Process models were used as baselines for re-engineering analysis, software tool gap analysis and user acceptance test design. End-to-end business process included demand forecasting, supply planning for inventory replenishment and dispositioning, capacity planning and MRP. Provided JIT training, and mentored a small team of business analysts in the practice of process modeling.
Paradigm Direct August 2000 to September 2000 (Ft. Lee, NJ)
Information Architect
Provided IT solutions for a start-up direct marketing company in a dynamic e-commerce application development environment that required rapid responses to support new business programs. Using Rational’s Unified Modeling Language (UML), developed a complete set of object models that represented the company’s core business processes, including: work flow diagrams, domain models / class diagrams, use-case specifications, sequence diagrams and collaboration diagrams. Authored a methodology for the development and revision of e-commerce computer applications.
Citibank August 1999 to February 2000 (New York City)
System Architect
Participated in a bank-wide application integration effort. Specified interface architecture for e-commerce, web-enabling middleware that provided a mechanism for the reliable delivery and traceability of messages between Citibank trade customers and trade back-end processing systems. Application allowed international export /import customers to initiate Letter of Credit requests on-line, executed (via middleware) by bank’s legacy trade financing applications, with execution results returned back to customer workstations. Developed end-to-end message flows across distributed software components. Created message formats (utilizing XML and SWIFT message protocols).
Produced system architecture and interface control documents, specifying the system components, the service request types and their process flows, the messages (including their format, validation rules and mapping rules), and system queues and test scripts. Resulting specification document was used to guide the development of the application utilizing IBM's MQ Series messaging software.
Pershing Securities October 1998 to August 1999 (Florham Park, NJ)
Enterprise Architect
Spearheading a company-wide enterprise data architecture re-engineering effort, employed Kimball methodology in developing dimensional data models (star schema) and test strategy for data warehousing effort. Aligned enterprise architecture to business strategy. Applied data sourcing, data mapping and data mining techniques to legacy data and applications. Identified the data value chains, defined meta-data using the Platinum Repository, and extracted business rules for the capture, classification and application of business intelligence / program algorithms. Produced standard data model templates, to be used as "starter" models by data modeling team. Performed forward- and reverse-engineering of logical data models spanning entire subject areas, using COOL:Enterprise.
Prudential Health Care July 1998 to October 1998 (Roseland and Princeton, NJ)
Systems Analyst / Process Improvement
Assessed the need for re-engineering an insurance claims processing application. Defined requirements, built logical models and drafted design solution alternatives for a Sybase RDBMS data warehouse pilot. Conducted business case analysis, cost /benefit analysis and feasibility study. Developed project plans for the development, implementation and migration project phases.
Automatic Data Processing (ADP) January 1998 to April 1998 (Roseland, NJ)
Enterprise Architect
Solely responsible for building a logical data model for an Enterprise Data Warehouse. Utilized Kimball methodology for the gathering / verification of data requirements, bottom-up synthesis of the logical data model and “star” representation of data structures for the data marts. Mapped data from legacy applications to data warehouse. Aligned enterprise architecture to business strategy.
Utilized the Zachman framework to build an enterprise model for ADP’s environment, facilities and operations. Used Rational’s Unified Modeling Language (UML) to develop a complete set of object models that represented the company’s core business processes, including: work flow diagrams, domain models / class diagrams, use-case specifications, sequence diagrams and collaboration diagrams.
Merrill Lynch June 1997 to December 1997 (Plainsboro, NJ)
Business Analyst for Distance Learning
For a business unit responsible for training more than 55,000 staff that was in transition from classroom instruction - to distance learning via video instruction - to web-based instruction, constructed a full suite of normalized conceptual models of the training business entities (e.g., catalog, course, curriculum) and their life-cycles. Built process models for: course development and offering, student enrollment, student progress and transcript maintenance. Models served as the basis for the design of a standardized distance learning program.
Lucent Technologies / IBM Global Services March 1997 to June 1997 (Warren, NJ)
Project Office / Process & Procedures Analyst
Participated in the start-up of a project office serving as the nerve center for all application development and maintenance (AD/M) activities under a massive outsourcing agreement. Project office managed and controlled the migration of the entire information technology (IT) function (including relocation of data centers, help desks, and support staff) from client to service provider. Responsible for design of process flows, business controls and clerical procedures.
Bayer / Insight Consulting Group November 1996 to January 1997 (West Haven, CT)
Process Methodologist
Specializing in object-oriented analysis (OOA), created a custom methodology to build information engineering (IE) models for use as inputs to object modeling activities. The methodology utilizes these IE techniques: event modeling, process modeling, logical data modeling, entity life cycle analysis (with state-transition rules), process / data interaction modeling and business rule analysis. Conducted use case analysis, business object modeling and object interaction diagramming using Rational’s UML.
IBM Global Services / ISSC January 1996 to July 1996 (Sterling Forest, NY)
Enterprise Architect
Built the logical data model for IBM’s procurement management function. Used the ADW CASE tool to model existing organization structure, business processes and data flows through the organization’s commodity procurement function. Logical models were used to direct the process engineering effort for an implementation of the SAP System R/3 procurement management module. Identified authoritative legacy data sources, and produced data mapping transformations. Conducted a gap analysis to assess goodness-of-fit for the application. Models were installed to IBM’s Intranet as an information resource.
PROFESSIONAL CERTIFICATION
Certified Six Sigma Green Belt (CSSGB)
Certified Management Consultant (CMC)
Certified Systems Professional (CSP)
PROFESSIONAL ACTIVITY
Institute of Management Consultants (IMC)
Data Administration Management Association (DAMA)
Association for Systems Management (ASM)
Institute for the Certification of Computer Professionals (ICCP)
process mapping, business process improvement, project plans, business analysis, workflow, management, data modeling, object modeling, Visio, .NET, Oracle, OOA, OOP, needs assessment, requirements gathering, business rules, technical specifications, team building, mentoring, system analysis, relational database, SDLC, methodology, computer science, client-server, analytical, SQL, Windows NT, validation, CFR Part 11, functional, documentation, logical, UML, balanced scorecard, metrics, BPMN, enterprise architecture, technical writing, authoring, data flow, data warehouse, internal controls, entity relationship diagram, facilitate workshop, develop business strategy, corporate modeler, rational rose, business case, use case, change management, metrics, translate, German, BDM, business domain modeling, SOAP, web services, Six Sigma Green Belt, XML, SOX, SarBox, swimlane, swim-lane, Documentum, TIBCO, SOA, SOBA, model driven architecture, MDA, Casewise Corporate Modeler,