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Work Experience
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CEO, Founder, Consultant
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October 2008 - Present
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WRC, LLC., Hartford, CT
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WRC provides cost-effective professional consulting services to businesses & consumers. We are centered on excellence, customer service, and work to empower the people within your organization to contribute to the success of your organization. Our current service offerings include: - ECM Consulting - Open Text Livelink System Administration services including:
- Workflow creation/modification
- Workflow troubleshooting/support
- Architecture/Installation/Configuration/Upgrade/Maintenance
- ECM Business Systems Analysis services including:
- Livelink CIS modeling and requirements analysis for new/upgrade implementations
- Preparation and execution of Livelink qualification activities (IQ/OQ/PQ)
- Migration to Livelink services from file systems or other DMS
- Qualification Templates - We offer both blank System Development Life Cycle (SDLC) templates and Installation/Operational (IQ/OQ) qualification templates to install/test Windows, Livelink, & SharePoint products in a controlled methodical fashion using industry best practice 'defaults'
- Digital Media Architecture (http://nVishionDigitalMedia.com/) - Full Service Digital Media Branding including Web Design, Content Management, Online/Social Media Marketing, Hosting, & Domain Registration Services. WRC uses the same tools we recommend, ensuring world-class customer service
- IT "Geek" Support (http://CTGeeks.com/) - We do it All! Game Consoles, iPod/MP3 Player & Home Theater Installation/Set-up, Computer Purchase/Set-up, Virus/Spyware Removal, Forensics, Security, Backup/Recovery, & Maintenance. Both on-site and remote service available for businesses & consumers
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Senior Consultant
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January 2008 - September 2008
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Glemser Technologies, Bethlehem, PA
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(Full-Time Employee, assigned to Pfizer projects) Glemser designs and implements content management solutions for life sciences companies. They provide world-class consulting, implementation and validation services as well as their own set of Documentum-based software applications. - Developed a set of functional requirements for an implementation of a SharePoint/NextDocs application at Pfizer by facilitating user requirements review workshops to clarify UR's and review corresponding FR's. Upon completion of the FRS, I assisted the application developers by creating an initial draft of the system design specification.
- Lead and performed system testing and validation (unit and integration testing, installation qualification, operational qualification, and performance qualification) for an implementation of the Adlib v4.x Product Suite in support of the DMF Infrastructure project at Pfizer.
- Provided strong analytical support during the requirements phase for an implementation of a customized version of xmLabeling (GDMS) for Pfizer Animal Health. Activities included leading Workshops to consolidate document groups and types across 9 business lines. This involved facilitating up to 30 business owners in an intensive three-day session. Other activities included requirements gathering and performing gap analysis of training materials.
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Systems Analyst/Developer III
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December 2005 - December 2007
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Watson Pharmaceuticals, Inc., Corona, CA
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(Full-Time Employee) Watson Pharmaceuticals, Inc. engages in the development, manufacture, marketing, and distribution of branded and generic pharmaceutical products in the United States. The company's products are used in various therapeutic areas, which include central nervous system, nephrology, hormones and synthetic substitutes, cardiovascular, and other areas. - Responsible for the planning, managing, and executing of technical activities related to the implementation and production support of an Electronic Document Management System (EDMS) using Livelink for Regulated Documents. The system provided functionality for the authoring, review, and electronic approval of department documents for Corporate Documentation, Development Operations, and Information Technology.
- Performed system configuration and integration testing including the functionality, performance, and fit to ensure that the system met the original requirements and worked within the defined constraints
- Evaluated system impact in consultation with the business, IS management, regulatory, IS development, quality assurance, validation, and training teams
- Provided input to effective change management, training requirements, and rollout plans to customers
- Livelink System Administrator duties included:
- Installation and configuration of Livelink server components
- Workflow map creation and management
- User and group administration
- Project/Folder creation and permissions management
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Informatics Advisor
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September 2001 - December 2004
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Pfizer, Inc., San Deigo, CA
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(Full-Time Employee) Pfizer, Inc. engages in the discovery, development, manufacture, and marketing of prescription medicines for humans and animals worldwide. - Advised the members of drug candidate teams on technology, business process solutions and new opportunities for automation. My focus was to provide continuity to the Global Candidate Team (GCT) by supporting the effective flow of information from data capture through to filing, post filing support and transfer to marketing.
- Worked as an integrated member of the GCT in support of meeting business critical goals and objectives
- Assisted with the preparation and conduct of Investigator Meetings and CRA Training
- Facilitated change caused by internal/external business drivers, including but not limited to, regulatory agency requirements (21 CFR Part 11), new technologies (eCTD), and outsourcing strategies
- Responsible for trouble-shooting cross-functional issues and seeking timely resolutions to minimize their impact on the GCT
- Provided leadership for the implementation of Livelink systems in support of the Clinical & Regulatory business lines. Maintained intimate contact with internal customers to identify end user needs and business best practices, while ensuring consistency with regulatory agency guidelines and requirements. Worked in a team environment with development, infrastructure and application support staff, along with global project team members to ensure system implementation & support goals were delivered as scheduled. Detailed project plans were developed and maintained to accomplish assigned tasks, thus ensuring project deliverables were on time, within budget, and met or exceeded customer expectations. Provided senior level management with frequent presentations on up-coming implementations for applications/processes and also with regards to existing project progress. Fulfillment of this role helped to ensure overall increased communications and knowledge share between Pfizer sites worldwide.
- Planned, coordinated, and enabled the delivery of an electronic Trial Master File (eTMF) using Livelink
- Enabled and supported the delivery of document imaging for the eTMF using Kofax
- Coordinated the vendor selection and process for the archival of Laboratory Notebooks (LNB) and supporting auxiliary data using PDF and DVD technologies
- Created and supported a check-out process for the delivery of LNBs on CD to scientists
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Principal Consultant
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October 1996 - September 2001
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Keane, Rocky Hill, CT
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(Full-Time Employee, assigned to Pfizer projects) Keane is a global services firm that specializes in enabling transformation of its clients' business and IT functions. The transformation partner of choice for clients across a broad array of industries, Keane is unique in its passion for building satisfying and enduring relationships with clients. - Managed the development work-stream of a next generation Case Report Form (CRF) imaging system (ECLIPSE) for worldwide deployment. This project involved gathering of user requirements and converting into system functionality, negotiations with outside vendors for software/services, and constant communications with global stakeholders to convey project updates, deliverable status, and current timelines. Supported by a team consisting of fifteen FTE/Contractors assigned by the client and $1M+ budgeted in combined services, software, and capital.
- System implementation included imaging/review system using Livelink, J2EE, and TELEform technologies (Now a core OpenText product: Livelink for Clinicals)
- Worked with customer stakeholders to design intuitive GUI and problem solving processes, while referring to 21 CFR Part 11 guidelines
- Established and coordinated an efficient system/user acceptance test process and environment, including overseeing the creation of system test scripts and supervising testing & fault resolution activities
- Authored project documentation in accordance with SDLC practices
- Led a successful team in the worldwide deployment of a commercial CRF imaging system. Initial responsibility involved restoring the application to a qualified status at one Pfizer site. Positive progress was achieved in 4 months and the project was completed in 6 months. By achieving project delivery excellence, I continued on to lead successive implementations at other Pfizer sites by directing a global team consisting of a mix of 8 FTE/Contractors assigned by the client. In this role, I also managed vendor communications to ensure satisfactory application development in addition to supervising system and user acceptance testing of each site release
- Assisted with the implementation of three systems using components of Livelink:
- Livelink in conjunction with Atlas, eLink, eForms, Explorer, MeetingZone, Online Office Document Editor, Recycle Bin for usage as a project team collaboration tool / document repository (InSight)
- Livelink in conjunction with Atlas, Casebook Generator, eLink, eForms, Recycle Bin for usage as a repository for Case Report Forms (ECLIPSE)
- Livelink in conjunction with Atlas, Attribute Extensions, Classifications, Collaborative Review and Approval, eLink, eForms, Enhanced PDF Renditions, Records Server, Recycle Bin, Review Manager for Acrobat for usage as a repository for Trial Master Files (ELARA)
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