- A certified PMP Project Management Professional program and project manager with extensive informatics experiences in leading and management of global teams, projects, processes and systems. Expertise in Systems Development Life Cycle SDLC , system migrations and management including systems in GxP environments GLP, GCP, GMP , and computerized systems validation CSV . Implementation lead in solutions delivery applications and infrastructure deployment and operation support and maintenance.
- Global experience supporting critical business services, translating business needs, and delivering innovative solutions and values to customers.
- Excellent communication skills and strengths in managing multi-cultural cross-functional teams in globally distributed environments. Known for exceeding user expectations in delivering solutions by being very flexible and transparent. Solid interpersonal skills with the ability to talk business, not just technology and the ability to lead and influence without authority.
- Established notable achievements in IT projects for global companies in various industries including: Pharmaceutical, Medical Devices, Financial, Accounting, Insurance, Media Publishing, Entertainment, Engineering, Aerospace, State Government, and Manufacturing.
Associate Director IT / Program Manager Global IT
- Managing multiple workstreams for global delivery of Pharmacovigilance solution for external customers.
- Specializes in planning and implementing SaaS solutions that provide Pharmacovigilance PV services to pharmaceutical companies.
- Establish risk issue management processes, and govern change control process for the PMO Project Management Office . Produce gap analysis, program dashboard status, RACI charts, manage end-to-end project plan, and resource plan identifying project's demand and capacity.
- Manage software development via SDLC and SOPs guidelines. Manage iterations provide workaround solutions and produce backlog tracking and burndown metrics for features in each iteration.
- Deliver solutions and align expectations by driving concerted efforts and collaboration among Quintiles departments involving project managers, subject matter experts, business analysts, technical architects, configuration engineers, system developers, and product support team.
Senior Project Manager / Program Manager- pREDi
Lead team implementing validated systems and transformational projects for Roche R D. Perform full life cycle system development and project management from requirements determination, test script development and execution, production deployment, and support. Own processes for idea and innovation collaboration and enterprise web-based collaboration. Manage systems and own end to end accountability and responsibility for providing services and solutions to the business. Manage and develop relationships with customers, and is the global single point of contact for the business.
- Formulating and defining scope and objectives of programs and projects and ensuring agreement and communication of project goals, scheduling baselines, and business direction to all stakeholders.
- Actively managing risks, assumptions, issues and dependencies by assessing potential impacts in collaboration with project teams and proposing appropriate mitigation actions.
- Elicit business and user requirements, and design and implement systems for Idea and Knowledge Management with collaboration and crowdsourcing HYPE Innovation Enterprise Wiki collaboration Atlassian Confluence Clustering Enterprise search for Business Analytics IBM Vivisimo business workflows and processes Microsoft SharePoint and GLP archiving and retrieval system to increase productivity.
- Author all GxP validation documents including user requirements, functional risk and system risk assessments, test plans, traceability matrix, test scripts, validation plans, summary reports, and change controls for GLP and non-GLP systems. Partner with Quality Assurance QA in delivering quality systems meeting specified requirements.
Manage project work stream for Pharma Executive Committee. Establish project governance, compliances GxP, and guidelines SOPs, GAMP for project deliveries within the constraints of time, resources, and budget with internal Roche departments and external vendors.
- Manage an External Business Partners ExBPs Registration Optimization Process project. This process improvement project produced a savings of 247,000.00 annually.
- Manage project work stream for global drug safety system replacement GCP . Oversee twenty team members and responsible for project budget of 5 million.
- Partner with Project Management Office PMO in establishing guidelines and best practices for different project type and size, and providing feedback to Project Health Status. Initiate risk management initiative by analyzing current risk assessment tools, surveying company-wide project managers, and recommending risk management process and tool to PMO.
Senior Project Manager
End to end service management responsibility for critical business application services for Pharma Development clinical systems. Act as a single point of contact for the business. Manage program and projects for validated solutions under services such as clinical information management systems, document management systems, and business data analysis and reporting.
- Manage and support clinical systems GCP such as RAPID Roche Automated Production of Integrated Dossiers regulatory document submissions to FDA IPS Investigator Payment System payment to investigators for clinical trials CASE Clinical Applications Staging Environment and Informatica PowerCenter for ETL extract, transform and load of clinical systems eCTD electronic Common Technical Document EDA/DM Exploratory Data Analysis/Data Mining Oracle Clinical and eLabeling prescription drug labeling .
- Establish GxP compliances for all applications going through changes and upgrades. Ensure service requirements are understood and met for capacity, availability, continuity and security based on SLAs, guidelines and standards SOPs and GAMP .
- Manage and coordinate change requests and ensure appropriate task delivery for infrastructure components according to plan under agreed scope, time, resources, quality and budget.
Global IT Lead / Project Manager
Lead Informatics role supporting the Global Messaging Collaboration systems and infrastructure. Support 80,000 users internationally on Exchange 2003 environment, including other services such as Outlook, Data Conferencing, Instant Messaging, Public Folders, Anti-virus, Anti-spam, Web Access, and Blackberry. Interact with global team members, Help Desks, end users, partner information services groups such as Customer Services, Directory Services, and Network Services to ensure consistent operation and support services.
- Introduce and responsible for service management metrics that defines the Service Level Agreements SLAs for messaging on a global, site, and regional basis.
Team Lead / Senior Technology Consultant HP Services
Project Manager/Senior Technology Consultant at numerous consulting engagements in various industries with strong emphasis on systems integration, solutions architect, systems migration and deployment. Examples include:
- Senior technical consultant at AOL Time Warner designing and implementing Active Directory AD and Exchange for 17,000 users. Demonstrated sales support skills and business writing skills by responding to RFP with a Statement of Work SOW , and a Letter of Engagement that was selected by Lifetime Entertainment.
- Trusted technology advisor for Siebe industrial automation messaging environment. Established roadmap for co-existence and integration of messaging systems and presented solutions to company CIO and IT staff.
- Messaging migration/deployment lead and support at KPMG. Project lead for email client testing and standards recommendation. Deployed and maintained Exchange for 25,000 users nationwide.
Technology Consultant / Trainer
Technology consulting and trainer at companies in different industries with strong emphasis on systems integration, network design, and deployment of IT infrastructure.
- Integrate and deploy systems for Eaton Cutler-Hammer's Windows NT Enterprise Network. Implement naming conventions, users' securities, and operational procedures. Administer and resolve issues for over 100 Windows NT servers at 90 locations throughout the country.
Consulting Associate / Training Specialist
IT consulting on business PC systems. Responsibilities include analyzing software, troubleshooting hardware, and programming database applications. Design and implement local area network and train users on operating systems, office applications, and multimedia programs.