SUMMARY

Skill Set: Business analysis, change management, client relationships, data migration, disaster recovery, integrated learning support, project management, ELC / SDLC methodology and documentation, pharmacovigilance, portfolio management, quality assurance (including FCPA, HIPPA, ISO 9000, Safe Harbor, SOX) / validation (EU / FDA, UAT), release management, requirement management, risk management (assessment / detection / mitigation), security, usability engineering, vendor management, workflow management System Expertise: Drug Safety, CAPA, clinical, CRM, DAM, dashboard, EDM, ERP, ETL, event tracking, infrastructure, MOM, MRM, SFA

Professional Experience

May 2009–present: Confidential,NJ. .
Role: Data Migration / Integration PROJECT MANAGER.
Responsibilities: Manage ETL and DAM development, multidivisional vendor–executed data migration / integration and deliverables (data profiling, source-to-target. requirements, data architecture) from ArisJ drug safety (pharmacovigilance) system and global proprietary drug safety system into ARGUS Safety / Insight and a statistical reporting data warehouse; develop requisite ELC documentation; oversee off-site vendors, validation, off-shore testers. and change management.
Systems/Tools: ArisG/J, ARGUS, Documentum, Microsoft Project / GNATT, Mercury Test Director, SharePoint. Trackwise, Visio

Jan. 2008–May 2009: Confidential,NJ.
Role: IT SALES & MARKETING PROGRAM MANAGER / BUSINESS ANALYST.
Responsibilities: Partnered with solution architect and global users to determine solution; gathered green-field business requirements, developed business / functional requirements for Global Medical Affairs: medical-legal review / submission / reporting, expert engagement/grant payment systems and requisite infrastructure pending SAP ERP / Siebel MRM and SharePoint portal implementation and rapid development of a Global Sales & Marketing product launch (promotional marketing) application and Siebel–based Conflict of Interest (COE) application; developed traceability matrix, test cases and summary (SLC), conducted user-acceptance testing; oversaw change management..
Systems/Tools: Aprimo MRM, Cognos, Documentum, First Doc, Interwoven Team Site, JIRA, Microsoft Project / GNATT, North-Plains Telescope, Protrack, Remedy, Siebel MRM/Pharma, SharePoint, TIBCO Business Studio BPM, Visio

Jan. 2007–Jan. 2008: Confidential,Raritan, NJ.
Role: Drug Safety PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Managed data migration and off-shore application development and enhancements to a proprietary global Web-based drug safety (pharmacovigilance) reporting system (incorporating CIOMS / PSUR & EMEA) in a validated environment; worked with US and EMEA users to gather region-specific business/functional requirements; developed project plan/schedule, design specifications, use cases, release/test plans; test cases/ summary report; test enhancements; designed application Web pages and regulatory reports; reviewed validation qualifications and SOPs (SDLC); oversaw change-management process; worked closely with QA to ensure global compliance.
Systems/Tools: Actuate, Documentum, Mercury Test Director, Microsoft Project / GNATT, Remedy, Trackwise, Visio

May 2006–Dec. 2006: Confidential,Whitehouse Station, NJ.
Role: IT SALES & MARKETING PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Managed off-site application and infrastructure development and enhancements to global clinical trials tracking system and Site Builder Web sites and G2 Single-Identity Remote Access portal (collaboration framework—Inform, Oracle, SQL. SharePoint, gathered green-field business requirements; developed project plan/schedule, use cases, functional requirements, design specifications, test plans, test cases, traceability matrix; prepared summary reports; developed global SOPs (SDLC); worked closely with QA to ensure global compliance.
Systems/Tools: ClearQuest, Documentum, Inform, Interwoven Team Site, Mercury Test Director, Microsoft Project / GNATT, Mime, SQL, Visio

Jan. 2005–May 2006: Confidential,Monmouth Junction, NJ.
Role: IT SALES & MARKETING PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Partnered with solution architect and global users to determine solution; drafted project plan/schedule, gathered best-of-breed business requirements, developed functional/design requirements for infrastructure supporting an SAP ERP implementation and remediation/integration involving 173 .Net/VB-Oracle/Lawson/Randstad/Controller Plus/AS400/MFGPRO/EDI/Galt/Sales Force Automation legacy applications and 279 data interfaces in a validated environment; developed use cases, test plan, test cases, test summary (SDLC) globalized training material; executed test cases; delivered instructor-led training; ensured ISO/Sarbanes-Oxley/EU compliance and change management procedures; worked closely with QA to ensure global compliance.
Systems /Tools:SQL, Mercury Test Director, Mercury Test Director, Microsoft Project / GNATT, TrackWise, Visio

July 2004-Jan. 2005: Confidential,Murray Hills, NJ.
Role: PROGRAM MANAGER/BUSINESS ANALYST/SOFTWARE QUALITY ASSURANCE for J.D. Edwards One World implementation.
Responsibilities: Drafted project plan/schedule, developed Sarbanes-Oxley/21 CFR Part 11/820 -compliant qualifications; reviewed test results, change requests, protocol results; developed use cases, policies/procedures/work instructions (SDLC) for J.D. Edwards One World with MES bolt-on (LDAP authentication) and MFGPRO ERPs, mainframe applications (including AS400), and infrastructure/middleware; worked closely with QA to ensure global compliance.
Systems/Tools: QUMAS DocCompliance, Microsoft Project / GNATT, TrackWise

Jan.-July 2004: Confidential,NJ.
Role:PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Drafted project plan/schedule, gathered best-of-breed business requirements; conducted risk analyses; developed use cases, traceability and roles/permission matrices (SDLC), and Sarbanes-Oxley/21 CFR Part 11/PDMA-compliant qualifications and SOPs for Great Plains ERP (financial/manufacturing/purchasing/inventory/sales modules; LDAP authentication) with MES bolt-on (Merit Life Sciences) involving Crystal reports/Oracle, production/Citrix/Veritas backup servers, standard infrastructure/middleware; developed data migration and retirement plans for MFGPRO, and security guidelines, and SOPs for NuGenesis and Web-enabled RAS VPN/SecurID; reviewed NuGenesis and DataCeutics qualifications.
Systems/Tools: BridgeTrack, SQL, QUMAS DocCompliance, Microsoft Project / GNATT, Visio

2003-04: Confidential,Raritan, NJ.
Role:PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Conducted front-end analysis to assess varied needs of 209 operating companies; developed use cases; and gathered
best-of-breed requirements for four-region, worldwide remote-access portal incorporating VPN//PKI token/iPass security/encryption technologies; developed 21 CFR Part 11/HIPPA/PDMA-compliant qualifications, traceability and roles/permission matrices (SDLC);developed/globalized integrated learning support (user/SA/OAM/Help Desk guides); managed/developed/reviewed SOPs and training videos; developed/globalized e-Portal content.
Systems/Tools: Documentum, Microsoft Project / GNATT, TrackWise, Visio

2002-03: Confidential,Hopewell, NJ.
Role:BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Modeled business processes; conducted front-end analysis to assess corporatewide needs; gathered green-field business requirements’ developed use cases and functional requirements for international deployment of Remedy client and Web-based Administration (LDAP authentication), Help Desk, Change Control (tracking), Reporting, Asset, Contact, SLA Management modules and ARGIS Asset Management/Documentum CoreDossier/SAP/Dendrite Sales Force Automation interfaces, and infrastructure/middleware; in compliance with cGXP, developed 21 CFR Part 11/HIPPA/PDMA-compliant traceability and roles/permission matrices, qualifications (SDLC); reviewed SOPs; directed Web-based training and test script development; managed user acceptance testing, gathered metrics, conducted root-cause analysis; worked closely with QA to ensure global compliance.
Systems/Tools: Documentum, Mercury Test Director, TrackWise, Visio

2001-02: Confidential,Raritan, NJ.
Role: PROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER.
Responsibilities: Drafted project plan/schedule; modeled business processes/network; conducted front-end analysis to assess needs of 209 operating companies; gathered best-of-breed business requirements, developed functional requirements for four-region, international Web-hosting network elements/applications—ATG Dynamo, Convera RetrievalWare, Documentum Web Content Management and CoreDossier, iPlanet, Resonate Commander—and Web-enabled bicorporate Remedy Help Desk; managed internal secure file transfer validation; worked with multiple organizations to develop and implement GXP- and FDA-compliant SOPs; conducted due diligence for external Web hosting; reviewed contracts/service-level agreements; drafted documents of understanding.
Systems/Tools: Documentum, TrackWise, Visio

Education:

Ph.D. Romance languages, M.A. mathematics, B.A. mathematics / economics