Résumé

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 9001, 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, MDM, MRM, SFA Professional Experience

Confidential, Bridgewater, NJ.
Role: SAFETY / RISK MANAGEMENTPROJECT MANAGER.
Responsibilities: Plan, direct, coordinate (1) ETL and DAM development, TrackWise upgrade; (2) multidivisional, vendor–executed data migration / integration; (3) 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 / statistical-reporting data warehouse; (4) and activities pertaining to IT infrastructure supporting the project; (5) develop requisite ELC documentation; (6) oversee off-site vendors, validation (21CFR Parts 11/ 300, Safe Harbour), off-shore testers. UAT, and change management;; manage IT portfolio (Clarity).
Systems/Tools: ArisG/J, ARGUS, Documentum, Excel / pivot tables, HP PPM / Quality Center,Microsoft Project / GANTT, Mercury Test Director, PowerPoint, SharePoint. TrackWise, Visio.

Confidential, Whitehouse Station, NJ.
Role: IT SALES & MARKETINGPROGRAM 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, Marketing Communications, and E-Discovery: review / submission / reporting, expert engagement/grant payment systems and requisite infrastructure pending SAP ERP / Siebel MRM and SharePoint portal implementation / data migration 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 (21 CFR Parts 11 / 200) and summary (SLC), conducted user-acceptance testing; oversaw change management; planned, directed, coordinated activities pertaining to the infrastructure supporting systems for five business units; managed IT portfolio (Clarity).
Systems/Tools: Aprimo MRM, Cognos,Documentum, Excel,First Doc,InterwovenTeam Site,JIRA,Microsoft Project / GANTT,HP PPM, Next Doc,North-Plains Telescope,Protrack,Remedy, Siebel MRM/Pharma, SharePoint, TIBCO Business Studio BPM, Visio.

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: TrackWise Actuate,Documentum, Excel,Mercury Test Director, Microsoft Project / GANTT, PowerPoint, Remedy, Visio

Confidential, Whitehouse Station, NJ.
Role: IT SALES & MARKETINGPROGRAM 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 / GANTT,Mime, SQL, Visio

Confidential, Monmouth Junction, NJ.
Role: IT SALES & MARKETINGPROGRAM 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 / GANTT,TrackWise, Visio

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 / GANTT, TrackWise

Confidential, Bridgewater, 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 / GAATT, Visio

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 / GANTT,TrackWise, Visio

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

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

Confidential, Peapack, NJ.
Role: PROJECT MANAGER/BUSINESS ANALYST.
Responsibilities:Drafted project plan/schedule; managed EDC/ E-journal/ERP/DMS and clinical software (Oracle Clinical, Clintrial, Clintrace) validation for various software solutions, including infrastructure/middleware; conducted front-end analysis to assess users’ needs; drafted validation/summary plans; developed functional requirements, traceability and roles/permission matrices (SDLC); reviewed SOPs, test scripts (21CFR Parts 200 / 300), and configuration/design specifications. Worked with multiple organizations to develop and implement GXP- and FDA/EU-compliant SOPs; drafted intranet requirements and globalization guidelines; managed user acceptance testing/user training; gathered user performance metrics, conducted root-cause analysis; worked closely with QA to ensure global compliance.
Systems/Tools: ArisG, Oracle Clinical, Clintrial, Clintrace, TrackWise

Confidential Piscataway, N J
Role: PROJECT MANAGER / SYSTEM ENGINEER for such global projects as In-Bound/Out Bound 800 Services, voice-recognition, prepaid telephone cards, LAN/WAN wireless service, and inventory-tracking systems, ATM/Frame Relay/IP/SDH/SONET/VOIP network-planning systems.
Responsibilities:Drafted project plans/schedules/test plans/test cases; developed system/GUI requirements/design specifications; managed MUT/PT/UAT cycles; conducted quality assurance audits (ISO 9000, CMM Level 5 compliance).

Education: Ph.D. languages, M.A. mathematics, B.A. mathematics / economics

Certification: Confidential PMP certification in managing technology

Languages: French, German, Italian, Portuguese, Spanish