RésuméSkill Set: Business analysis, change management, client relationships, data migration, disaster recovery, integrated learning support, partner / vendor management, portfolio management, project management— ELC / SDLC/ RAD ? Agile methodologies 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, workflow management System Expertise: Drug Safety, CAPA, clinical, CRM, DAM, dashboard, EDM, ERP, ETL, event tracking, infrastructure, MOM, MRM, SFA Professional Experience

December 2011-Present: Confidential, Bridgewater, NJ. . 
Role: SAFETY / RISK MANAGEMENTPROJECT MANAGER. 
Responsibilities: Plan, direct, coordinate RAD / Agile development to implement (1) partner E2B data exchange, (2) ICSR quality review portal, (3) Global Drug Safety dashboards, (4) semi-automatic BO compliance reports—Safety Alliance Management, Development Safety Update; (4) manage project portfolio; (5) conduct stakeholder/ status meetings; (6) develop requisite ELC documentation; (7) oversee on-site / off-site development, vendors, validation (21CFR Parts 11/ 300, Safe Harbour), off-shore testers. UAT, and change management; 
Systems/Tools: ARISg/j, ARGUS, Documentum, Excel / pivot tables, HP PPM / Quality Center,Microsoft Project / GANTT, Mercury Test Director, PowerPoint, Remedy, SharePoint. TrackWise, Visio.

June. 2011–December 2011: Confidential, Whitehouse Station, NJ.
Role: GHHT SALES & MARKETING ITBUSINESS ANALYST.
Responsibilities: Partnered with solution architect, usability engineer, and business unit to determine solution; led Agile rapid application development sessions, gathered green-field business requirements, developed business / functional requirements for Marketing Communications asset toolbox; developed traceability matrix, test cases (SLC), conducted user-acceptance testing; oversaw change management. 
Systems/Tools: Documentum, Excel, HP Quality Center, North-Plains Telescope,Power Point, SharePoint

May 2009–June 2010: 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; 
Systems/Tools: ArisG/J, ARGUS, Clarity, Documentum, Excel / pivot tables, HP Quality Center,Microsoft Project / GANTT, Mercury Test Director, PowerPoint, SharePoint. TrackWise, Visio.

Jan. 2008–May 2009: 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. 
Systems/Tools: Aprimo MRM, Clarity, Cognos,Documentum, Excel,First Doc,InterwovenTeam Site,JIRA,Microsoft Project / GANTT,Next Doc,North-Plains Telescope,Protrack,Remedy, Siebel MRM/Pharma, SharePoint, TIBCO Business Studio BPM, Visio.

Jan. 2007–Jan. 2008: Confidential, Raritan, NJ.
Role: Drug SafetyPROGRAM MANAGER/BUSINESS ANALYST/VALIDATION ENGINEER. Responsibilities: Managed data migration and off-shore rapid 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

May 2006–Dec. 2006: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

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

Certification: AT&TProject Management certification in managing technology