Experience

Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Sr. IT Project Manager - R&D (Consultant)

  • May 2020 - Oct 2020

  Morris Plains, New Jersey, United States • Veeva Clinical & CDMS Vault (CTMS / eTMF / EDC). • docuBridge for Publishing. • SAS-LSAF and Pinnacle21 for Statistical Programmer and Data Standards. • JReview for Data Management and Medical Affairs.



Eisai US

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. IT Project Manager - R&D (Consultant)

  • Jul 2019 - Dec 2019

  • Electronic Trial Master File (eTMF) • Clinical Trial Management System (CTMS)



Smith+Nephew

• United Kingdom
• Medical Equipment Manufacturing
• 700 & Above Employee

• IT Program and Project Manager - R&D (Consultant)

  • Mar 2018 - Jun 2019

  • Clinical Trial Management System (CTMS) • Electronic Trial Master File (eTMF) • Electronic Data Management System (EDC) • System Integration between CTMS, EDC, Safety DB and eTMF • Drug Safety Database (Safety DB) • Work with Validation Team for System Validation for UAT and Technical & Business Go-live. • Managed Project Budget, Project Plan, Scope, Risk and Issues, work with Finance BP for actuals and forecast.



Novartis

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• IT Project Manager ( Consultant )

  • Jul 2017 - Jan 2018

  East Hanover, NJ • Program and Project Management. • Work with business partner and stakeholder to provide Business Solutions. • Risk & Issues, Project Budget, Vendor and Stakeholder Management. • Financial forecast vs actual spend. Work with Financial Analyst Business Partner. • Lead PM for Saleforce and SAP COE. • Integration Lead to Salesforce, SAP, LIMS and other applications. • 21CRF Part 11 validation. • Operation Support for CAR-T applications. • Develop Solution Architecture for… Show more • Program and Project Management. • Work with business partner and stakeholder to provide Business Solutions. • Risk & Issues, Project Budget, Vendor and Stakeholder Management. • Financial forecast vs actual spend. Work with Financial Analyst Business Partner. • Lead PM for Saleforce and SAP COE. • Integration Lead to Salesforce, SAP, LIMS and other applications. • 21CRF Part 11 validation. • Operation Support for CAR-T applications. • Develop Solution Architecture for CAR-T along with the Enterprise Architecture team. • Manage patient Chain Of Identity (COI), from initial scheduling, the “harvest” of T-Cells. • Manage logistics to and from a processing site, monitoring during the cell modification process and re-infusion. • New Product Launch initiation to readiness. Show less



Sunovion Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• IT Program and Project Lead - R&D

  • May 2014 - Jun 2017

  Fort Lee, NJ • Implement and provide operational support for global Clinical Trial Management System. • Provide operational support to LIMS system. • Integrate CTMS with other major application like EDC, IVRS and CIMS • Coordinate CSV activities with the QA team for 21CFR Part 11 compliance. • Implement and manage Clinical Development Analytics (CDA) for reporting and visualization. • Experience with Clinical Data Warehouse (CDW). • Vendor Management, prepare SoW, coordination activities… Show more • Implement and provide operational support for global Clinical Trial Management System. • Provide operational support to LIMS system. • Integrate CTMS with other major application like EDC, IVRS and CIMS • Coordinate CSV activities with the QA team for 21CFR Part 11 compliance. • Implement and manage Clinical Development Analytics (CDA) for reporting and visualization. • Experience with Clinical Data Warehouse (CDW). • Vendor Management, prepare SoW, coordination activities from initiation to completion. • Led a team of 4+ people and closely work with the business on Project and support activities. • Managed Capital and Operational budget and forecasting. • Experience with eTMF for clinical trial documents tracking. • Manage Project schedule, issues, risk and budget. • Experience working with stakeholders in Japan, China, India and UK. Show less



Forest Laboratories (now Allergan)

• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Project Manager - Research Informatics R&D

  • Nov 2012 - Mar 2014

  Jersey city, NJ • Implement global Clinical Trial Management System (CTMS) with 5K+ users. • Manage multiple vendors for SaaS application hosting. • Implement eTMF for tracking clinical trail documents and Risk-base Monitoring. • Implement Publishing and eCTD application for FDA submission. • Led a 12+ person team comprised of Business and Systems Analyst, Technical Architect, QA Lead, and off-shore technical team. • Draft business case and cost benefit analysis to gain budget authorizations… Show more • Implement global Clinical Trial Management System (CTMS) with 5K+ users. • Manage multiple vendors for SaaS application hosting. • Implement eTMF for tracking clinical trail documents and Risk-base Monitoring. • Implement Publishing and eCTD application for FDA submission. • Led a 12+ person team comprised of Business and Systems Analyst, Technical Architect, QA Lead, and off-shore technical team. • Draft business case and cost benefit analysis to gain budget authorizations. Crafted project and operation budgets. • Coordinate project schedules, issue resolution, risk management and budgets. Show less



Warner Chilcott (now Allergan)

• IT Program Manager

  • Jan 2007 - Nov 2012

  Rockaway, NJ • Report to IT leadership team. • Manage relationship with senior level Clinical, R&D and Regulatory IT organization. • Clinical Trial Management System (CTMS) for Clinical Department. • ELN/LIMS solutions for Laboratory Management System (SAPPHIRE, LabWare, etc). • ARGUS, IRMS, InSight etc applications for pharma-covigilance and Medical Affairs. • Integration experience with ERP system. • Oracle Clinical and Remote Data Capture (OC and RDC). • SIEBEL Sales Force… Show more • Report to IT leadership team. • Manage relationship with senior level Clinical, R&D and Regulatory IT organization. • Clinical Trial Management System (CTMS) for Clinical Department. • ELN/LIMS solutions for Laboratory Management System (SAPPHIRE, LabWare, etc). • ARGUS, IRMS, InSight etc applications for pharma-covigilance and Medical Affairs. • Integration experience with ERP system. • Oracle Clinical and Remote Data Capture (OC and RDC). • SIEBEL Sales Force Automation (SFA) implementation for sales organization. • QUMAS and Documentum for Enterprise Document Management system (EDMS). • Experienced with IBM SCORE, ISI Publishing and eCTDXPress for eCTD submission. • Led regulatory and Publishing organization for Electronic FDA Submission via E2B. • Evaluated Oracle Life sciences Data Hub (LSH) and Empirica Signal. • Oracle Enterprise Database RAC environment (9i/10g/11g) for the entire organization. • Trackwise for CAPA, customers complain, investigation, deviation and CR. • I-Many and Model N for Government Pricing. Show less



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager / LIMS Consultant

  • Jul 2006 - Dec 2006

  New Haven, CT • Report to head of business unit. • Define SOP for process improvement • Responsible for managing day-to-day IT and LIMS operation • Work with business unit and vendor to implement new functionalities.



LabVantage Solutions, Inc

• United States
• Software Development
• 700 & Above Employee

• Technical Project Manager

  • Feb 2002 - Jun 2006

  Bridgewater, NJ • Report to VP of Professional Service • Participate in white board session with the global customer. • Manage a team of Business Analyst and solution engineer for solution implementation using the flag ship product SAPPHIRE • Work in developing new functionality for High Through put informatics and storage module using J2EE Technology. • Work in converting client server application to an n-tire J2EE solution. • Experience in managing international resources and outsourcing… Show more • Report to VP of Professional Service • Participate in white board session with the global customer. • Manage a team of Business Analyst and solution engineer for solution implementation using the flag ship product SAPPHIRE • Work in developing new functionality for High Through put informatics and storage module using J2EE Technology. • Work in converting client server application to an n-tire J2EE solution. • Experience in managing international resources and outsourcing efforts. • Provide project update to all the stakeholders. • Directly engaged in managing offshore and onsite resources. Show less



TCG Software Services, Inc

• Consulting Analyst

  • Feb 2000 - Jan 2002

  Edison , NJ • Report to the VP of Business Consultant • Identified and managed construction of new user interface pages using Java and JSP technology • Defined conversion strategy for the client from legacy LabVantage product developed in Power Builder to the new Web architecture. • Managed global implementation team both on-site and offsite. • Facilitated design meetings, implementation plan, and performed technical review and analysis of completed prior to submitting to the client. • Part… Show more • Report to the VP of Business Consultant • Identified and managed construction of new user interface pages using Java and JSP technology • Defined conversion strategy for the client from legacy LabVantage product developed in Power Builder to the new Web architecture. • Managed global implementation team both on-site and offsite. • Facilitated design meetings, implementation plan, and performed technical review and analysis of completed prior to submitting to the client. • Part of team overseeing and managing company’s India operation and outsourcing program for US clients. Show less



TCG Software Services Private Limited

• Software Engineer

  • Nov 1997 - Feb 2000

  • Report to the Head of Center Operation • Work on US Project team in developing design, functional specification and reengineering of the application. • Developed and maintained software application using Active Server Pages, VBScript, Visual Basic5.0, Crystal Reports, MS SQL Server 6.5 • Responsible for developing various user interaction pages, ActiveX and back end DLL objects. • Coordinate onsite acceptance testing at various testing sites (seaports).



Sahul Finance Ltd

• Software Executive and Hire Purchase Assistant

  • Jan 1997 - Dec 1997

  • Report to Chief Operating Officer • Responsible of developing in-house application for the business using Visual Basic and MS SQL Server and MS Access • Data modeling, back end triggers and store procedure. • Perform unit and validation testing



Arkay Computers

• Senior Programmer

  • Aug 1995 - Dec 1996

  • Report to Head of Operation • Served as Business Analyst by participating in feasibility study and requirement analysis. • Documented initial project specification, scope and data modeling. • Designed and developed GUI elements using forms, menus etc. with Visual Basic 3.0 and Access 2.0 • Created test plans and conducted unit and system tests.