SUMMARY

• Over 20 years of project management experience in the Pharmaceutical, Software Development, and Internet sectors.
• Drug Safety Pharmacovigilance expert
• Project Manager and Designer of software product that integrates world’s leading medical information system with ARISg drug safety software.
• Project Manager for numerous Argus Drug Safety upgrades
• Project Manager for numerous migrations to ARISg and Argus drug safety systems
• Project Manager for integration projects of drug safety systems due to pharma or biotech companies being acquired by another Pharma
• Drug Submission expert (NDA’s, IND’s, etc.) using Liquent Suite and data from Documentum and EDC systems such as Oracle Clinical and Medidata Rave
• Trained and experienced in PMI/PMP, Prince2, PERFORM, and Agile methodologies.
• Very experienced managing global projects for C level executives.
• Vast knowledge of worldwide regulatory requirements and validation requirements of the pharmaceutical sector.
• Adept at bridging the gap between business users and IT.
• Additional professional functional expertise includes business analyst, validation expert, testing manager, and software developer.
• Other skills include:
• FDA and EMEA regulations including 21 CFR Part 11.
• Software validation and testing and have written, executed, approved and signed IQ, OQ, PQ documents, Master Validation Plans, and change controls.
• Project manager for many international projects.
• Technical and design lead of a commercial Project/Program Management software package.
• Process improvement.

TECHNICAL SKILLS

• Microsoft Project/Microsoft Project Server
• Tableau
• Axway e2b (formerly Cyclone and Synchrony)
• Oracle SQL and PL/SQL
• MSSQL and T - SQL
• Business Objects
• Crystal Reports
• Document Management
• TrackWise
• Argus Safety
• AJAX
• Documentum
• UML
• Microsoft .NET
• ADO
• ASP
• ASP.NET
• ADO.NET
• HTML
• XML
• Access
• Sybase
• DB2
• EDI
• Perl
• PowerBuilder
• UNIX (various flavors)
• LINUX
• Visual Basic
• Microsoft .NET languages
• JavaScript
• Enterprise Work Management
• Enterprise-Wide Program Management
• Enterprise-Wide Document Management
• Visual Test
• Oracle
• SQL Server
• VB.net
• C#
• Data modeling
• Cognos
• Business Objects

PROFESSIONAL EXPERIENCE

Confidential

Principal Consultant

Responsibilities:

• Consolidated disparate drug safety systems into new Argus system
• Managed Veeva 17R5 upgrade and validation
• Rolled out Oracle Trace and FDA AERS database
• Managed SAS migration

Confidential

Senior Project Manager

Responsibilities:

• Analyzed current Drug Safety system issues to create project plan to consolidate all existing systems internally and bought in via acquisitions to move towards one Argus multi-tenant platform
• Created migration plans for 2 existing systems to new Argus multi-tenant platform

Confidential

Senior IT Project Engineer

Responsibilities:

• Ashfield supports multiple pharmaceutical companies by utilizing the multi-tenant capabilities of Argus.
• Customized reports and processes to meet the contractual details of their client base.
• Ashfield had a 6-month backlog of open tickets regarding feature requests, open issues, etc from their client base.
• Was able to get their backlog down to 4 weeks.

Confidential, Fort Worth, Texas

Senior Project Manager

Responsibilities:

• Project manager to upgrade and improve the worldwide Regulatory publishing system. Scope grew from worldwide Alcon to include partner companies and eventually Confidential .
• Integrated data from EDC systems (Oracle Clinical, Medidata Rave) into Documentum for publishing NDA’s, IND’s, etc.
• Managed international project to migrate and consolidate all existing document management systems into one new Documentum system.
• Responsible for all publishing submissions to FDA by supporting our Liquent software suite and Documentum systems.
• TrackWise administrator
• Responsible for support of Medical Information system.

Confidential, Woodridge, Illinois

Drug Safety Development Leader

Responsibilities:

• Implemented improved project management processes to better manage our existing client base.
• Managed development of new software product that allows clients to move data from OBA Medical Information system to ARISg and Argus systems.
• Subject matter expert in Drug Safety for current software product (IRMS). IRMS is the worldwide market leader in Medical Information Systems.
• Managed project to design prototype for first generation of IRMS Drug Safety product to compete with current market leaders (ARISg and Oracle’s Argus Safety)
• Led technical and functional testing of existing software releases
• Developed Traceability Matrices and IQ/OQ/PQ scripts for IRMS Drug Safety implementation at 3 major pharmaceutical companies.
• Designed AE triage system for major pharmaceutical client

Confidential, Deerfield, Illinois

Senior Project Manager

Responsibilities:

• Created or reviewed all validation documentation (SOP's, Master Validation Plan, Traceability Matrix, IQ/OQ/PQ Testing deliverables, and Data Migration Plans for worldwide roll-out of Argus Safety 4.2 system.
• RCA root-cause analysis along with corrective & preventive action (CAPA) documentation and analysis for Drug Safety systems and Drug Publishing systems.
• Primary support for Argus Safety 4.2 worldwide (Japan, Europe, US). Supported all Argus web servers, Synchrony application, Argus Database, ESM module. Created custom reports. Managed all user accounts. Developed/Approved/Reviewed validation documentation.
• Primary support for ECTDXpress. This software is used for compiling, reviewing, and archiving eCTDs and submissions to the FDA and for all Documentum based systems used in Astellas US. These include the submissions system and the SOP system as well as various other systems.
• Integrated data from EDC systems (Oracle Clinical, Medidata Rave) into Documentum for publishing NDA’s, IND’s, etc. using ECTDXpress
• Primary support for Global Submit software. This software is used to validate submissions to the FDA. And for InfoMaestro. This solution combines Documentum with Siebel Customer Relationship Management (CRM) to deliver timely, accurate, and compliant information directly to customers or customer-facing employees easily.
• Validation and upgrade of TrackWise system.

Confidential, Stamford CT

Principal Consultant

Responsibilities:

• Principal consultant in our life sciences division, which is focused on drug safety and regulatory affairs, research and development, data management, clinical trials and supply chain operations.
• Worked with clients to create customizations to ARISg drug safety.

Confidential, NY

Senior Consultant

Responsibilities:

• Documented all current business processes pertaining to Drug Safety reporting for the pharmaceutical company, Confidential .
• Prioritized all known processes and workarounds that would be needed for first stage roll-out of their new Argus Drug Safety database system due to it being an off-the-shelf system rather a custom developed system. Performed gap analysis and created business requirements for Phase II of project.
• Developed in-house drug safety program for Confidential to teach new consultants the various regulations, definitions, work-flow, and validation that is part of the drug safety process.

Confidential, Tarrytown NY

CIO

Responsibilities:

• Project manager for development of digital asset management system that is now in use at many advertising agencies.
• Provided technical leadership to all 60 employees and managed all IT contractors.

Confidential, Stamford CT

Project Manager/ Senior Analyst

Responsibilities:

• Successfully led implementation and roll-out of all international software implementation.
• Performed business analysis of Medical Education system to streamline all processes related to symposiums and lectures. And on taxonomy creation for Library systems and document management systems globally for Purdue.
• Project Manager for implementation of custom developed drug safety application called AES. This adverse event system was used by all of Purdue’s associates in North America.
• This system was later replaced by Argus Safety.
• As project manager, led development of worldwide document management system.
• This system contains most of the scientific and statistical assets of the company and is used to create NDA’s (new drug applications to FDA); created the design specification for the new Documentum system.
• I then reviewed the design specifications with the key stakeholders to ensure conformance with requirements and FDA regulations.
• Integrated data from EDC systems (Oracle Clinical, Medidata Rave) into Documentum for publishing NDA’s, IND’s, etc using CoreDossier
• Led JAD sessions with members of Legal, Regulatory Affairs and Drug Safety for creation of a Postmortem toxicology system.
• Created Business Requirements documentation and documented any legal or regulatory issues; developed system individually and had it developed, validated and rolled out in only two months.
• This application was used to assist the company in handling spurious lawsuits filed against them in relation to drug OxyContin.
• Resulting application saved the company many millions of dollars in lawsuits.
• Managed project to migrate existing FileNet document management system to Documentum 3.0 based system.
• Documented all change controls and conducted train-the-trainer sessions for roll-out of new system.
• Performed requirements definition for project portal site that consolidates information from all drug trial projects. Conducted interviews with two separate Project Management groups and members of the scientific community. The resulting portal pulled together data from many disparate systems into one system to give a birds-eye view of the companies projects so it was also necessary to create IT process flows so the impact of any changes in existing systems would not pose any issues for the portal.
• Conducted meeting and interviews with members of technical operations at all levels to create requirements for development of a disaster recovery system. Created SOP’s and helped the teams in creating their disaster recovery “cookbooks’.

Confidential, Houston TX

Senior Consultant

Responsibilities:

• Gathered requirements from ‘data champions’ that were responsible for all the various groups for Confidential worldwide.
• The system needed to handle 90% of Confidential ’s intellectual assets.
• Due to security concerns was tasked to create a design specification that would protect data as much as possible while still allowing people to find and use the information they needed.
• Helped merge the requirements and the stringent security matrix into a detailed design specification.

Confidential, White Plains, NY

Senior Analyst

Responsibilities:

• Managed technical support group. By implementing a more effective troubleshooting methodology and developing troubleshooting guides, increased average per person productivity from 34 calls a day to 62 while also increasing member satisfaction from 63% to 92%.
• The lower personnel needed combined with the decrease in callbacks (members calling back because earlier calls did not fix problem) resulted in an estimated savings of at least $300,000 per year