SUMMARY:

Manage and provide support to businesses and IM through implementation of enterprise level applications and custom integration solutions. Effectively managing global resources throughout SDLC implementation and integration of applications across pharmaceutical companies to harmonize business processes for competitive advantages.

SKILLS:

PM Methodologies: Jira, Microsoft Project, MS Office (PowerPoint, Excel, Word, Visio), Project Charter, Issues Log, SDLC, Waterfall, Agile, Scrum, Clarity, Instantis, PMx, ClearQuest, Instinct (EtQ Reliance)

Programming Languages: SQL, PL/SQL, Visual Basic, HTML, .NET, SAS, XML, XSL/XSLT, ASP

Databases: Netezza, SQL Server, Oracle 9i & 10g, MS Access

Computer System Validation: Standard Operating Processes (SOPs), Master Validation Plan, IQ/OQ/PQ/VSR, Traceability Matrix, Business Requirements Document (BRD), Functional Requirements Document (FRD), System Design Document (SDS), Problem Reporting (CAPA), GxP (GCP, GMP, GLP), 21 CFR Part 11

Operating Systems: Windows 95/98/NT/2000/XP/Vista/Windows 7, MS Dos, Mac OS

Web/Mobile Application Platform: Sharepoint, Microstrategy, Documentum, ARISg, WebSDM, Salesforce.com, Polaris, CYA Technologies, ISI Toolbox, Mobile Application (iOS)

Data Integration: Informatica, MoveIT Central, MBox

PROFESSIONAL EXPERIENCE:

Confidential, West Chester, PA

IT Project Manager

Responsibilities:

• Serve as the Technical Project Manager for projects related to the Confidential Synthes Mobile Application and Digital Asset Management Systems supporting global Medical Device business partners: Biomaterials, CMFCodman Neuro, Joint Reconstruction, Power Tools, Spine, Trauma, and Vet. Responsibilities includes:
• Managed the MediaBin v8.3 System Upgrade project to move DAMS from Confidential Synthes to J&J infrastructure.
• Serve as the PM, System SME (Architect/Installation/Configuration), Validation Lead, and Data Migration Lead
• Led the Data Migration Validation workstream with Computer Systems Validation and Database teams.
• Led and coordinated transitioning of current sFTP tool to Mbox as part of MediaBin Upgrade v8.3 project.
• Coordinate and facilitate infrastructure tasks in coordination with project Beyond using EMPIR tool.
• Accountable and responsible for all Instantis & PMx activities/tools for development projects.
• Accountable and responsible for validation deliverables and processes in alignment with J&J SDLC procedures.
• Lead and support ongoing system development operations, enhancements, and prototypes.
• Technical liaison between Internal team (US/EMEA) and implementation vendors for system enhancements.
• Transitioned and trained internal resources on system, technical, and/or internal processes.
• Manage the Digital Asset Management System User Audits per internal processes and procedures.
• Resolved 2 CAPAs for the Digital Asset Management System leveraging Instinct (EtQ) application.
• Implement metrics and dashboards for Digital Asset Management and Mobile Application Systems.

Confidential, King Of Prussia, PA

Project Manager

Responsibilities:

• Managed a global VB to VB.NET conversion project for Treasury & Risk Management system.
• Successfully deployed the system to 200 clients within 6 months.
• Managed across functional and geographical teams (i.e. developers, QA testers).
• Facilitated daily scrum sessions with project team.
• Worked closely with internal business partners Product Support and Customer Support to ensure all reported bugs and QAs are addressed according to SLA.
• Prioritized product backlog for Major and Minor maintenance releases.
• Generated project plan for change request through the team planning system, Jira Ecofinance.
• Worked closely with Product Management and PMO office on resource and capacity planning.
• Managed project risk through comprehensive mitigation assessment and planning techniques.
• Established strong relationships with stakeholders, core team, managers, and cross functional departments building awareness and continue support.
• Facilitated weekly meetings with sponsor committee providing transparency and visibility for projects assigned.
• Effectively mentored resources to achieve business solutions within project guidelines.
• Worked collaboratively with other project managers/leaders to coordinate cross - project initiatives & activities.
• Identified and eliminated obstacles to solution plans, business goals, or implementation.

Confidential, Chadds Ford, PA

R&D IM Project Manager

Responsibilities:

• Provide IT technical support for the R&D organization, ranging from installation, configuration, customization, and generation of all validation documents (IQ, OQ, PQ and Summary Reports) to support changes to validated systems.
• Partner with business in leading R&D technology road map projects for GCP, GMP, and GLP organizations:
• Managed an implementation of a Clinical Trial Dashboard system integrating SharePoint, Microstrategy, SAP, EDC and Netezza data warehouse to track clinical trials and providing metrics, reporting and dashboard to the R&D organization supporting various clinical trial studies.
• Executed a flawless implementation of SAS and Netezza data warehouse integration for longitudinal medical claims data (Commercial Claims, Medicare Supplemental, and Medicaid) to increase performance productivity for data extraction and full study analysis from days to hours/minutes.
• Responsible for managing off-shore resources to implement Business Object Reporting for ARISg, an Adverse Event and Safety system.
• Led a successful implementation of WebSDM system allowing the Statistical programming team to verify final derived datasets against SDTM standards before submission to the agency.
• Managed flawless implementation of Clinical Supplies Inventory (CSI) to track clinical study supplies.
• Responsibilities for above projects include:
• Data architect (logical/physical modeling) for Netezza data warehouse.
• Provide guidance and direction to project team for both business partners and IT resources: Informatica, Microstrategy, SharePoint developers and Netezza Administrators.
• Facilitate workshop sessions to identify current and future processes meeting business requirements.
• Manage and negotiate vendors’ SOWs, contracts & pricing, resources, and timelines.
• Facilitate execution of contractual agreements and capital appropriation requests with Legal and Procurement.
• Present STAR framework to upper management for capital appropriation and support.
• Manage project timeline, budget, internal and external technical resources throughout project lifecycle.
• Communicate weekly project scorecards to business partners and upper management teams.
• Facilitate monthly meeting with sponsor committee until project closure.
• Managed 2 phases of Documentum DCM 5.3 SP3 implementation and migration of legacy system supporting GxP organizations (GMP, GCP, and GLP).
• Managed a team of 10 resources (i.e. technical developers, analyst, and validation sub-team).
• Responsible for budget, project plan, resources, and validation efforts using standard SDLC methodology.
• Co-lead with external validation manager to work with internal QA department for GxP validation efforts.
• Facilitated and coordinate with training coordinator to author training materials and train 200+ end users.
• Managed implementation vendor for Disaster Recovery and backup system for Documentum.
• Instituted Documentum governance framework via team charter and RACI across IM and business partners.
• Established timely metrics and dashboard to upper management and business stakeholders throughout SDLC and post implementation for trending.
• Negotiated deliverables and project scope due to company re-org with business partners/vendors/sponsors.
• Provision over technical integration efforts between Documentum & ComplianceWire to automate data feeds.
• Managed Documentum support resources adhering to governance and internal controls.
• Worked with business and IM partners to identify opportunities for improvements harmonizing business processes and technologies.
• Oversee the EDGAR Business Governance and ESTA committees to ensure no negative impact to different sites for system and process changes.

Confidential, Malvern, PA

Software Consultant

Responsibilities:

• Technical lead responsible for the development of web-based solutions to support regulated intranet and extranet web sites for branded products.
• Translate business requirements to technical specifications.
• Improve awareness of product pipeline by developing .NET and ASP websites for consumers.
• Identify process pain points and recommend remediation plans and tools to enhance business processes.
• Worked collaboratively with development, configuration, deployment, and validation teams to test and debug applications using .NET, ASP, and Java technology.

Confidential, Horsham, PA

Technical Project Lead

Responsibilities:

• Worked independently and led small technical team to evaluate web architecture and deliver appropriate integration solutions to customers. This includes, evaluating customers' content management and publishing processes, web application architecture and configurations, security requirements, and provide detailed documentation for custom solutions that satisfies the customers' business and technical requirements.
• Partnered closely with customers and pre-sales teams to manage and implement customer trials, propose technical feasible solutions and set accurate expectations on effort and timelines for integration. Established success criteria and act as the single point of contact for all technical issues and project deliverables.
• Created and managed proposals, Statements of Work and detailed project plans for customer integrations including timelines and effort estimates. Worked closely with Account Management, Sales professionals and engineering to resolve issues that arise during customer integrations.
• Managed and developed Documentum applications along with technical developers creating custom objects, lifecycles and workflows via the Application Builder and Workflow Manager.

Confidential, Horsham, PA

Senior Software Developer

Responsibilities:

• Led and developed along with development team to implement the following:
• Internet applications using Microsoft Visual Studio .NET and Oracle 9I with ODP.NET. It serves as a company portal that integrates with Netegrity Single Sign-on and Verity Full Text Searching capabilities.
• Web-base application for the International Institute of Education using Visual Interdev ASP pages and Microsoft Access database. Responsibilities include: taking on the role of an Account Manager for communications ensuring all deadlines and deliverables are met, requirements gathering, implementation and development of the application along with technical team.
• Web application for Internal Ad Tracking System using Visual Interdev ASP and Oracle 9i integrated to Mainframe database (Adabase) through extraction, transformation, and loading process via scheduled jobs. Responsible for requirements gathering, development, integration, testing and implementation.
• Developed desktop application for scheduling of events, media, and news to be aired live on television by CSPAN. Utilizing Visual Basic 6, VSFlexGrids and ActiveToolBars as the front-end and Oracle 9I database with Oracle Object for OLE (OO4O) as the backend.
• Responsible for development of a web application to scrub, cleanse, and transform data received from client using Visual Interdev ASP pages before loading into SQL Server database.

Confidential, Malvern, PA

Internet Developer

Responsibilities:

• Led the development of third party tool integration to SAP and other business systems such as development of web-based application (eReq) electronically handle business rules, accounting controls and workflow process associated with processing of a requisition from input to approval. It automatically transfers the approved requisition to SAP for conversion to a purchase order and follows through to the payment process.
• Worked closely with SAP Business analysts and other functional persons to determine requirements, business processes and programming specifications (i.e. procurement and financial teams).
• Created an on-line vacation request system. Responsible for designing, development and implementation of this application using MS InterDev and ASP as the front end and fully integrated into SQL Server 7.0 and MS Exchange databases.