- Eighteen years experience with in-depth background in full lifecycle, large-scale information system implementations. Possess excellent customer service skills, while interacting and supporting customers and cultivating secure corporate impression to ensure project success. Expertise in project planning, identifying work plans, considering priorities, forecasting problems, envisioning solutions and following-up efficiently. Extensive backgrou
- nd in leadership, management, business analysis, developer supervision and documentation. Strong analytical skills for understanding business processes, business rules and requirements, and application architecture. Strong experience working in GxP regulated SDLC environments.
Confidential West Point, PA
Sr. Project Manager
- Actively worked with business SME’s to build business cases, project plans and change requests for new applications in a validated/regulated pre-clinical IT environment.
- Managed all business communications including requirement/scope definition for projects, status updates, issue resolution and steering committee meetings.
- Managing 3 project teams, budgets (1-5MM), plans, deliverables, vendor relationships and all related communications.
- Mentored analysts and developers in building IT solutions for process improvement amongst the business/client community.
- Actively involved in architecting the solutions based on SharePoint and .NET technologies for clinical trials including patient recruitment/retention, clinical document authoring and approvals, electronic trial master file, learn management systems etc.
- Implemented SDLC for application development based on Agile and Waterfall methodologies.
- Worked with the project stakeholders in determining overall project strategy; coordinating systems and operational needs to support significant changes in products, policy, procedure or programs.
Sr. Project Manager / Business Architect
- Worked in a Project Manager/Business Architect role at IMS Health involved in multiple data warehousing, analytics and web services development projects.
- Conducted numerous requirements gathering sessions with the business leaders and translated the business requirements into functional and system specifications in liaison with the technical architecture and development teams.
- Worked closely with the business community and the PMO office to build business cases, project plans, change requests, ROI analysis, gap analysis, UAT testing and obtain buy-in/acceptance. Presented business and technical solutions to all levels of management to obtain project sanctions and approvals.
- Developed elaborate test cases for all data and functionality validation scenarios to facilitate end to end testing in a strict SDLC environment, worked closely with the testing teams in creating test scenarios and certifying the test results.
- Worked as a liaison, with the business users and development team to gather, interpret, and define the business, functional and technical requirements for system enhancements, modifications, error corrections, and/or new systems/functionality for Clinical Data Repository (CDR) system. CDR provides a single data repository for all clinical patient data (CRFs) and enables reporting across drug and vaccine programs.
- Created and managed project plans, authored business cases / proposals and managed the approval process with the change control board.
- Closely worked with the business standards teams and the development teams in implementation of the CDISC Study Data Tabulation Model (SDTM) for the clinical data repository, identifying gaps and providing solutions leading to full SDTM compliance.
- Extensively utilized UML (Use Cases, Swim Lanes, Activity/Sequence diagrams) for requirements analysis and technical/architecture discussions in a Service Oriented Architecture(SOA) environment.
- Facilitated user acceptance testing by business users and developed testing guidelines. Conducted weekly status meetings and managed issue resolution with the development team.
- Performed product release management. Managed change requests (Clear Quest / Remedy / Quality Center) and tracked issues as on-going project support tasks.
- Authored Merck SLC documentation for change requests, requirements, use cases, user acceptance specifications and summary, requirements traceability matrix, SOP's etc in compliance with Merck ’s validation standards and GXP regulatory standards .
- Performed lead role in software gap analysis, ROI analysis and product selection. Heavily involved in selecting the Siebel CTMS product to replace the current Clinical Trial Management application.
- Made presentations to a variety of audience – technical teams, senior executives and the RadPharm Board to gain buy-in and approval.
- Identified the Siebel implementation vendor after conducting an extensive vendor selection / negotiation process and was the single point of contact for initial implementation effort.
- Identified and organized project Steering Committee and Business Process Owner groups (SME’s) for all modules. Chaired JAD sessions, created business architecture and process workflows for the Siebel implementation in an Agile development environment.
- Worked as a liaison, with the business users to gather, interpret, and define the business, functional and technical requirements for system enhancements, modifications, error corrections, and/or new systems/functionality for variety of projects including Finance, HR, BPM, Clinical Trials Management and Reporting.
- Worked as a business architect on Workflow Management System (WMS) project that is a BPM solution using eRoom custom extensions and Documentum content server. This product is used to manage clinical trial processes used in processing and reading Radiology media. This application is currently being migrated to Siebel.
- Created and managed multiple project plans and resources for successful project execution. Performed analysis of user tasks and complex business workflows.
- Authored variety of documents including Project Charters, Vendor/Software Selection Reports, System Requirements Specifications etc in compliance with 21CFRPart 11 regulatory environment.
- Performed impact/gap analysis for incorporating National Provider Identifier (a new industry identifier mandated by HIPAA) as the primary identifier for doctors and hospitals in all IMS systems internally and client reporting systems.
- Since NPI impacts all the existing applications at IMS, was responsible for meeting with all the business users in understanding the risks and effects it may have on their existing system/application.
- Created project concept and presented to senior management.
- Conducted meetings with all levels of management and user communities to gather business and functional requirements.
- Proposed business and technical solutions to issues and obtained approvals from stakeholders.
- Working as a liaison, with the clinical users to gather, interpret, and define the business, functional and technical requirements for system enhancements, modifications, error corrections, and/or new systems/functionality, which will become the basis for defining the scope of a project.
- Work with users in incorporating their requirements with features (workflows, security, organizing data, etc).
- Review project requests and provided sizing estimates for business requirement and functional design specification efforts.
- Created the High Level Design for this application.
- Actively contributed in the preparation of system life-cycle documentation. Was a contributing author to the Functional / System Design Specification and Version Description documents.
- Responsible for all phases of the systems development life cycle.
- Managed the development of a client server based applications that were built using Visual Basic .NET, .NET Remoting, Visual Basic 6.0, COM, Oracle 9i and Crystal Reports .
- Created the High Level Design for this application and performed code reviews.
- Used Documentum Foundation Classes to upload and modify documents in a Documentum docbase.
- Conducted weekly status meetings, managed change requests and tracked issues as on-going project support tasks.
- Responsible for leading unit testing, integration testing, acceptance testing and system deployment. Resolved daily issues with the technical team, and conducted client review and feedback sessions. Also provided post implementation change request support.
- Managed a team of 2 developers and 1 analyst in the creation of Deloitte Consulting education site for their consultants on e-commerce and e-business implementation. Used Visual Interdev 6.0, Visual Basic 6.0, ASP, XML, XSL, HTML, SQL Server 7.0 to create a dynamic architecture and for storing page contents.
- Served as a technical point of contact for the global users.
21 CFR Part 11 and Introductory GMP / GCP / Regulatory Training