AREAS OF EXPERTISE
- 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 wif excellent organizational and written and oral communication skills.
- TEMPEffective Communicator to all Levels of teh Organization.
- Certified Project Management Professional (PMI - PMP)
- Lean Six Sigma Yellow Belt (LSSYB)
- Program Management / Project Management
- Stakeholder Engagement and Management
- Vendor Management
- Strategic Leadership
- HIPPA Compliance
- MS Project
- MS Office
- SharePoint / BOX
- 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 Training
- Highly Organized
- Strong Analytical Skills
- TEMPEffective Communication Skills
- Excellent Oral & Written Skills
- Customer Service
- Healthcare / Life Sciences / Pharmaceutical / Biopharmaceutical / Medical Device / Clinical Trials
Program Manager / Sr. Project Manager
Confidential, Bethlehem, PA
- Serve as Project Manager responsible for planning, coordinating, and executing multiple client IT projects in teh biotechnology industry.
- Manage international based project teams to meet defined scope, schedule, budget, and resources.
- Collaborate wif 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 Confidential for Medical/Pharmaceutical Device Co.
- Serve as Project Manager responsible for teh 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 teh Clinical Trials industry.
- Build and maintain strong partnerships wif all levels across teh organization as well as TEMPeffectively interact wif 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 wif 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 training.
- Partner wif 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
- 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 training 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 wif 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 wif 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 wif 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.
Confidential, Bedminster, NJ
- 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 wif third party & internal applications.
- Coordinated resources, to ensure all projects are wifin timelines, budget & client needs.
- Partnered wif Finance & Off-shore teams to align plans, resources, and budget.
- Identified and tracked technical issues, interacting wif Product Team and offshore technical teams.
- Served as teh liaison between teh client and technical teams to ensure requirements are met.
- Monitored and communicated project status to teh 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 wif client PMO to manage account governance and change management.
- Managed a team of four software developers, supporting 22 active implementations.
Confidential, Hazlet, NJ
- 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 wif 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
- Developed, tested and deployed a Training 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 teh 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 wif 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 teh 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 wif stakeholders, vendors and team members.
- Managed and supervised 10 direct project team resources (internal and external).
- Communicated TEMPeffectively wif both technical and non-technical parties.
- Partnered wif other Core PGM application teams to ensure future system integration.
- Shared project strategies and documentation wif other Confidential divisions to create cross-divisional synergies.
Project Manager/Business Analyst
Confidential, Clinton, NJ
- Worked as a Consultant for Pharmaceutical client - Confidential .
- Identified internal and external systems to evaluate for a Core Training Management (LMS) solution.
- Developed a Process to evaluate and select teh Training Management system.
- Reviewed, analyzed, and evaluated business and end user needs to define system functionality for teh Training 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 Training Materials for End Users.
- Conducted training sessions on departmental SOPs and Change Control Procedures.
Confidential, Skillman, NJ
- Served as liaison between corporate training department and divisional SAP training teams.
- Conducted 3 end user surveys to assess SAP training TEMPeffectiveness for SD, MM and FI modules.
- Identified training gaps and made recommendations for user training, cost TEMPeffectiveness and company synergies.
- Created and deployed intercultural training program for employees.
- Managed temporary personnel wifin teh department.