Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Continuing Education
Summary Of Experience
Key Qualifications
Continuing Education
Summary Of Experience
Software
George W. Warner

George W. Warner

Doylestown,PA

Summary

SR. PROGRAM/Project Manager (PMP Certification) with 25+ years of Information Technology (IT) experience in the highly regulated pharmaceutical industry with key emphasis on systems integrations for clinical trial, data management and analysis and reporting supporting processes. Combines drive, experience and performance with integrity to deliver value to the business through technical solutions.

Qualified Program/Project Manager with solid background in managing and implementing technology solutions. Known for successfully leading cross-functional teams to deliver complex projects on time and within budget. Demonstrated expertise in stakeholder management and process optimization, enhancing overall operational efficiency.

Overview

25
25
years of professional experience

Work History

SR. PROGRAM / Project Manager PMO

Merck
04.2011 - Current
  • Responsible for all aspects of complex projects, from scheduling, budgeting, resourcing and driving to completion
  • Work with Business to understand key business and functional requirements, and work with implementation team to ensure that all requirements are fully met in solution
  • Responsible for multiple projects with budgets in excess of $10 million, including monthly and annual reconciliation of capital and expense budgets from internal and vendor cost centers
  • Lead a migration of over 100 Oncology clinical trials to a new platform which included the coordination of efforts with the Study Teams, IT, Outsourced partners and the hosting provider (Oracle) resources
  • Lead Business Case development through Proof of Concept and subsequent Implementation projects of new electronic case report form development platform, drawing together Business and Technical teams to evaluate solution and identify key strengths, challenges and opportunities associated with the implementation of the product
  • System was implemented following SDLC standards
  • Managed the successful implementation of the several systems as part of a major strategic systems integration program, at the same time as carrying out responsibilities for cross-program project planning for budget and resources
  • Projects were conducted for one of the top Pharmaceutical companies in the world - within budget and on schedule
  • Additional Program Level responsibilities include Vendor management (budgets, forecasts, accruals, and resource management) for contracted work
  • Currently leading one of the top priority projects in the company for the client, involving their Oncology portfolio of clinical trials

SENIOR BUSINESS SYSTEMS ANALYST

PR Newswire
08.2010 - 03.2011
  • Facilitates the solicitation of business requirements for the core Editorial system; translates business requirements into tangible software specifications, Use Cases and other software design artifacts; coordinates analysis and testing activities with other internal technology groups and third party suppliers; provide leadership to other business system analysts
  • Lead efforts to introduce standard processes where few existed, including introduction of Agile methodology principles; worked effectively in a complex working environment with key stakeholders of the primary Editorial system for the company
  • Lead complex effort to introduce first iteration of eCommerce functionality into customer-facing and internal systems (integrating back-end Oracle Financial system)
  • Lead team in a business process analysis of the way project and release requirements gathering and clarification is done, leading to a more effective project and release workflow
  • Mentoring of other BAs in Agile methodologies

SENIOR IT LEAD/PROJECT MANAGER

SmithKline Beecham/GlaxoSmithKline
03.2006 - 08.2010
  • Responsible for elicitation and prioritization of requirements for regulatory reporting applications
  • Role of SCRUM master for Agile implementation
  • Responsible for ensuring that all documentation followed the SDLC standards for requirements and other technical documents
  • Responsible for gathering the system integration requirements for the PhaseForward / InForm system and overseeing the implementation of these requirements into the pre-production and validated production EDC environment
  • Reviewed Business Requirements and authored System Requirements for the core system
  • Reviewed Test Cases for adherence to requirement specifications
  • Met with FDA representatives to defend adherence to GSK standards
  • Ensured that applications were developed, deployed and maintained throughout their production use and formally decommissioned according to GSK Standards
  • Responsible for the successful analysis, planning and execution of IT Continuity Planning for Critical and Mission Critical GSK systems

PROJECT MANAGER/ BUSINESS ANALYST

SmithKline Beecham/GlaxoSmithKline
01.2003 - 03.2006
  • Responsible for eliciting, clarification and prioritization of requirements and subsequent development and implementation of the next generation Electronic Data Capture (eDC) technology for GSK
  • I was ultimately accountable for the quality of the application delivered for eDC use for GSK

CLINICAL STUDY OPERATIONAL PROJECT MANAGER

SmithKline Beecham/GlaxoSmithKline
01.2002 - 01.2003
  • Responsible for Operational Project Management for oncology trials for pediatric post-operative nausea and vomiting

EDM SUPPORT REPRESENTATIVE

SmithKline Beecham/GlaxoSmithKline
03.2000 - 01.2002

Education

BS - Education

Trenton State College, Trenton, NJ
GPA: CUM-LAUDE

Diploma - Computer Programming

Chubb Institute of Technology, Parsippany, NJ
GPA: with Highest Honors

Continuing education through Oracle Educational Services, The Chubb Institute of Technology, Microsoft Educational Services, ESI International, PMI, Six Sigma training

Skills

  • Business analysis
  • Software development lifecycle
  • Product management
  • Requirements gathering

Solution design

Stakeholder management

Cross-functional team leadership

Teamwork and collaboration

Team collaboration

Relationship building

Project leadership

Continuous improvement

Accomplishments

  • Supervised a cross-functional, multi-national team of both Business and IT staff members to accomplish the migration of the Merck oncology portfolio from one eDC platform to another without disruption to study execution or loss / compromise of clinical data.
  • Achieved multiple process improvements through effectively collaborating with various Business Units to improve efficiency and reduce time to completion.
  • Achieved process consistency and efficiencies by introducing process automations for completion, handoff and tracking of migration tasks across functional units distributed worldwide.
  • Achieved full transparency of up-to-date status tracking by introducing utilities and dashboards for commuication tasks.

Timeline

SR. PROGRAM / Project Manager PMO - Merck
04.2011 - Current
SENIOR BUSINESS SYSTEMS ANALYST - PR Newswire
08.2010 - 03.2011
SENIOR IT LEAD/PROJECT MANAGER - SmithKline Beecham/GlaxoSmithKline
03.2006 - 08.2010
PROJECT MANAGER/ BUSINESS ANALYST - SmithKline Beecham/GlaxoSmithKline
01.2003 - 03.2006
CLINICAL STUDY OPERATIONAL PROJECT MANAGER - SmithKline Beecham/GlaxoSmithKline
01.2002 - 01.2003
EDM SUPPORT REPRESENTATIVE - SmithKline Beecham/GlaxoSmithKline
03.2000 - 01.2002
Chubb Institute of Technology - Diploma, Computer Programming
- , Continuing education through Oracle Educational Services, The Chubb Institute of Technology, Microsoft Educational Services, ESI International, PMI, Six Sigma training
Trenton State College - BS, Education

Continuing Education

  • Oracle Educational Services
  • The Chubb Institute of Technology
  • Microsoft Educational Services
  • ESI International
  • PMI
  • Six Sigma training

Summary Of Experience

  • 20 years’ experience in Clinical/Regulatory environment in Pharmaceutical industry
  • Extensive experience in SDLC practice and adherence
  • Experience with outsourcing project work and vendor management (contracts, budgets, resourcing)
  • Experience with implementation of COTS products and large systems integrations
  • 15+ years of Technical (Development and Systems Integration) and Clinical Project Management experience
  • PMP Certification (#1568446) through PMI (ID #2524509)
  • Matrix management experience with onshore and offshore teams
  • Six Sigma Green-belt trained
  • Excellent analytical, interpersonal, verbal and written communication skills
  • Ability to interact and work effectively with individuals at varying levels of an organization
  • Excellent business partner liaison skills

Key Qualifications

  • Solution Manager (PMP Certification) with 20 years of Information Technology (IT) experience in the pharmaceutical industry with key emphasis on systems integrations for clinical trial, data management and analysis and reporting supporting processes.
  • Combines drive, experience and performance with integrity to deliver value to the business through technical solutions.

Continuing Education

  • Oracle Educational Services
  • The Chubb Institute of Technology
  • Microsoft Educational Services
  • ESI International
  • PMI
  • Six Sigma training

Summary Of Experience

  • 20 years’ experience in Clinical/Regulatory environment in Pharmaceutical industry
  • Extensive experience in SDLC practice and adherence
  • Experience with outsourcing project work and vendor management (contracts, budgets, resourcing)
  • Experience with implementation of COTS products and large systems integrations
  • 15+ years of Technical (Development and Systems Integration) and Clinical Project Management experience
  • PMP Certification (#1568446) through PMI (ID #2524509)
  • Matrix management experience with onshore and offshore teams
  • Six Sigma Green-belt trained
  • Excellent analytical, interpersonal, verbal and written communication skills
  • Ability to interact and work effectively with individuals at varying levels of an organization
  • Excellent business partner liaison skills

Software

MS Project

MS Excel

MS Powerpoint

MS Word

SQL

Visual Basic for Applications

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George W. Warner