SUMMARY:

• Certified Project Manager Professional offering 20 years of Project Management experience.
• 15 Years’ Experience in IT/Software Implementations for Pharmaceutical/Lifesciences/Healthcare.
• Client - facing Project/Program Manager who manages matrix teams in regulated environments.
• Leader who applies project management expertise, methodologies, and standards to achieve goals.
• Team Player with excellent organizational and written and oral communication skills.
• Effective Communicator to all Levels of the Organization.

TECHNICAL SKILLS:

• MS Project
• MS Office
• SharePoint / BOX
• Planview
• TEMPUS
• JIRA
• Tableau
• Agile Methodology
• Waterfall Methodology
• Business Intelligence (BI)
• Data Warehousing (DW)
• Software Development Lifecycle (SDLC)
• Cross-Functional Team Building
• Requirements Gathering and Analysis
• Change Management
• Problem Management / Problem Resolution cGMP / GxP
• Systems Integration
• Data Migration
• Software Implementation
• Software Testing
• System Validation
• Software Documentation
• End-User
• Highly Organized
• Strong Analytical Skills

PROFESSIONAL EXPERIENCE:

Program Manager / Sr. Project Manager

Confidential, Bethlehem, PA

Responsibilities:

• Serve as Project Manager responsible for planning, coordinating, and executing multiple client IT projects in the biotechnology industry.
• Manage international based project teams to meet defined scope, schedule, budget, and resources.
• Collaborate with Procurement, Business and Vendor teams to secure licensing, SOW, vendor contracts, project costs, funding, timelines, and resources.
• Provide weekly and monthly reports to PMO, BRM and Sr. Executive Stakeholders for status on project timelines, scope, budget resourcing and risk mitigation.
• Serve as Project Manager responsible for implementing Labware LIMS for Medical/Pharmaceutical Device Co.
• Serve as Project Manager responsible for the implementation of BI/Analytic solution to Healthcare Clients for Quality and Compliance initiatives from a vendor perspective.
• Implement solution to Life Sciences clients for Sunshine Act/CMS Open Payments compliance.
• Implement SaaS solution for Safety Report Distribution in the Clinical Trials industry.
• Build and maintain strong partnerships with all levels across the organization as well as effectively interact with senior management and remote staff.
• Initiate and monitor project scope, schedule and costs from Kickoff to Project Closure.
• Develop internal Project Portfolio Dashboard to track and control portfolio and program status, schedules, budgets, resources risks and changes to provide company-wide visibility.
• Facilitate Business Requirements definition and solution design meetings for Data Warehouse, Analytics Reports, and Executive Level Dashboarding across multiple EMRs.
• Possess understanding of regulatory and health care guidelines relating to systems and processes.
• Create and manage detailed project plans with milestones, dependencies, and critical path.
• Develop project charters, communication plans, RACI, budgets and resource allocations.
• Author Internal/External Deliverables for Requirements and Change Management
• Track and control change orders, potential risks, project issues and contingency plans.
• Develop, plan and execute all documents for system testing and end user .
• Partner with Client Vendors to ensure Data Migration and Systems Integration success.
• Perform Data Analysis and Data Mapping of Clients Source Systems for Data Migration.
• Conduct Internal Testing of Base Product to identify system bugs/enhancements.

Technical Project Manager

Confidential, Princeton, NJ

Responsibilities:

• Served as Project Manager / Technical Lead to implement Spend Tracker/Disputes Manager and Check Request systems to Pharma/Medical Device companies in a client facing role.
• Managed IT Software Implementation projects from kick-off through deployment.
• Defined and managed project scope, goals, schedule, cost and deliverables supporting PMO goals.
• Developed internal Project Portfolio Dashboard to track portfolio and program status, schedules, budgets, resources risks and changes to provide company-wide visibility.
• Deployed standard processes and tools to identify, prioritize and manage company Dashboard to track all program activities including status, delivery indicators and issues.
• Communicated project status to include budget, timelines, risks, and remediation to Sr. Management / PMO.
• Identified and managed project dependencies and critical path, escalating as necessary.
• Developed progress reports, change requests, system requirements, system and PPT presentations.
• Managed Change Requests to include requirements, business cases, cost, duration, and user acceptance.
• Created a standard process for Concur - ADE mappings.
• Developed Interface for processing CMS emails and Itemized Expenses Loads from CMS.
• Collaborated with Internal teams to communicate & manage change requests and deviations.
• Determined Need and Cost Justification for additional staff and/or consultants.
• Facilitated client-facing workshops to solicit business and functional requirements for current and future state.
• Lead cross-functional teams of DEV, Product Management, QA, and external vendors.
• Documented technical requirements and design specifications for implementation.
• Worked with Compliance Attorney to translate customer/regulatory Sunshine Act requirements into system functionality.
• Identified, documented, tested and managed system deviations for both Product Base functionality and client specific configurations.
• Managed all system defects and enhancement by conducting daily and weekly meetings with off-shore Development & QA Teams.
• Utilizing Agile methodology, prioritized DEV/QA tasks for client Software Release Sprints.
• Enabled continuous improvement by identifying successful and unsuccessful project elements and recommending better ways to accomplish goals.
• Standardized and Deployed Internal SOPs, Templates and Client Deliverables relating to Software Implementations, Production Launch and Client Support to ensure consistency.
• Communicated and Trained Internal Personnel on newly created SOPs, Templates and Client Deliverables.

Project Manager

Confidential, Bedminster, NJ

Responsibilities:

• Served as Client-facing Project Manager who deployed multiple solutions of Aggregate Spend and CRM solutions totaling over $3 million in revenue.
• Managed SaaS environments, including integrations with third party & internal applications.
• Coordinated resources, to ensure all projects are within timelines, budget & client needs.
• Partnered with Finance & Off-shore teams to align plans, resources, and budget.
• Identified and tracked technical issues, interacting with Product Team and offshore technical teams.
• Served as the liaison between the client and technical teams to ensure requirements are met.
• Monitored and communicated project status to the project team & Executive PMO levels.
• Prepared SOW, budgets, and Project Plans to determine scope, budget, resources.
• Maintained MS Project Plan, budget, and all Deliverables from inception to deployment.
• Updated all system documentation to ensure system design/deployment meets requirements.
• Collaborated with client PMO to manage account governance and change management.
• Managed a team of four software developers, supporting 22 active implementations.

Project Manager

Confidential . Hazlet, NJ

Responsibilities:

• Worked as a Project Manager to determine project scope, requirements, and budget.
• Facilitated client - facing meetings to define project scope, objectives, and timelines.
• Conducted needs assessments and requirement gathering meetings with SMEs.
• Documented system specifications, functional requirements, and process workflows.
• Utilized MS Project to determine project scope, requirements, and resources.

IT Project Manager

Confidential, Peapack, NJ

Responsibilities:

• Developed, tested and deployed a Management System (LMS) for PGM-Human Resources Division.
• Developed, tested and deployed a Corrective/Preventative Action System (CAPA) for Corporate QA Division.
• Created, deployed and supported 60+ CORE international/global software site implementations for both LMS and CAPA projects.
• Developed cost analysis, justification, project charters, budgets and scope for each system.
• Provided strategy, cost, timelines, system deliverables and expectations to each PGM site.
• Facilitated requirement / JAD sessions to identify and document business & IT requirements.
• Conducted an RFP/Vendor selection process for each Global system.
• Participated in several Vendor Audits as part of the Vendor selection process.
• Audited each system to ensure FDA and GMP compliance including 21CFRPart 11.
• Validated each application by creating and executing validation test plans (IQ, OQ, PQ).
• Created and maintained all SDLC system documentation to support each application.
• Worked with internal clients, IT Dept., and vendors to determine requirements and scope.
• Created and managed project budget vs. actual expenditures (capital and expense).
• Authored and maintained project plans from the design phase through project completion.
• Managed all deliverables utilizing formal Change Management process in Documentum.
• Built and managed teams to resolve issues through weekly cross-functional meetings.
• Provided communications and presentations to project stakeholders and divisional leaders.
• Built and maintained strong relationships with stakeholders, vendors and team members.
• Managed and supervised 10 direct project team resources (internal and external).
• Communicated effectively with both technical and non-technical parties.
• Partnered with other Core PGM application teams to ensure future system integration.
• Shared project strategies and documentation with other Confidential divisions to create cross-divisional synergies.

Project Manager/Business Analyst

Confidential, Clinton, NJ

Responsibilities:

• Worked as a Consultant for Pharmaceutical client - Warner Lambert/ Confidential .
• Identified internal and external systems to evaluate for a Core Management (LMS) solution.
• Developed a Process to evaluate and select the Management system.
• Reviewed, analyzed, and evaluated business and end user needs to define system functionality for the Management System.
• Determined and managed departmental budgets and project plans using MS Project.
• Revised service level agreements between IT and end users.
• Defined end user workflows, user requirements, traceability matrix and validation documents.
• Created and revised SOPs, Change Control Procedures, Validation protocols.
• Prepared various types of Materials for End Users.
• Conducted sessions on departmental SOPs and Change Control Procedures.

Consultant

Confidential, NJ

Responsibilities:

• Served as liaison between corporate department and divisional SAP teams.
• Conducted 3 end user surveys to assess SAP effectiveness for SD, MM and FI modules.
• Identified gaps and made recommendations for user, cost effectiveness and company synergies.
• Created and deployed intercultural program for employees.
• Managed temporary personnel within the department.