We provide IT Staff Augmentation Services!

Senior Program\project Manager Resume

Boston, MA

SUMMARY

  • More than 20 years of experience as Project Manager and Validation Specialist in Healthcare, Pharmaceutical, Laboratory, Manufacturing and Medical Devices.
  • Highly successful Project Manager for the implementation, application management and support for Pharmacovigilance (Argus), Quality Management Systems (Master Control), and Clinical Trial Management Systems.
  • Long track record of successes as a Project Manager, Validation Specialist, and Solution Architect in developing implementation strategies, creating timelines, determining resources, developing budgets and implementing technical and business process solutions.
  • Strong relationships and understanding of need to bridge gaps between Information Technology, Solution Implementors (vendors), Clinical Operations, System Quality Assurance, Technical Quality Management, Enterprise Infrastructure and Project Management Office.
  • Experienced in Life Cycle Development, Mission Value Methodology, and Solution Review for the implementation of Commercial Off the Shelf, (COTS), internally developed systems, applications and reports.

TECHNICAL SKILLS

  • Oracle Relational Database Management Systems, Oracle Clinical Electronic Data Capture, Remote Data Capture, Thesaurus Management System, Veeva Vault, BluePrint, iRise, and Requisition Pro, Information Request Management System.
  • Received Confidential ’s highest individual performance award from the Executive Vice President for Exceptional Achievements in Problem Solving and Process Improvement.
  • Insight Reports, Axway Interchange, JIRA, Confluence, Assyt, Change Management System
  • Microsoft Word, Excel, PowerPoint and SharePoint

PROFESSIONAL EXPERIENCE

Confidential, Boston, MA

Senior Program\Project Manager

Responsibilities:

  • Project Manager responsible for $3.8 million PAREXEL’s Oracle Argus 8 Update and implementation of Multi - Tenant environment.
  • Determined stakeholder objectives and translated goals into key project milestones. Setup Steering Committee meetings, interviewed and met with Executive Leadership Team, Business Owners, System Owners, System Quality Assurance, and Information Technology leads (Architecture, Enterprise, Release Management, and testing).
  • Managed project deliverables, timeline and resources that drive tasks and activities to completion. Setup work stream meetings, conference room pilots, and virtual dry runs. Track vendor contracts, Statements of Work (SOW), Master Service Agreements (MSA) and vendor.
  • Reviewed and commented on Request For Information, vendor performance evaluations, and vendor security assessments. On-boarded subject matter experts, consultants, contractors and performed vendor management for the projects.
  • Defined high-level project documentation such as Business Charter, Business Case, Business Requirements Document, Project Initiation and Request, Project Plan, Project Risks Assessment, Planning and Financials.
  • Created Communication Plan, Change Management, Weekly, Monthly Status Reports, and ensured delivery of over 200 project artifacts based on agreed upon milestones, plans and timelines.
  • On-boarding Business Analyst to contribute to the business requirements, SOPs, Work Instructions, workflows for the Argus Safety System projects upgrade.
  • Setup Discovery Workshops, vendor demonstrations, conference room pilots to build team knowledge and understanding of requirements, vendor capabilities and to ensure alignment with business and stakeholder requirements.
  • Expert knowledge in Project Management, Validation and Business Analyst and deep understanding of pharmaceutical industry cross-functional areas including: Clinical Trials, Safety, Data Management, Quality Assurance, Regulatory, Sales, Marketing, Information Technology and Finance.
  • Performed upgrades, system and application implementation of complex systems like Argus Drug Safety/Pharmacovigilance and Clinical Trial Management System.
  • Experienced in the creation, tracking and testing of User Requirements in Waterfall or Agile scrum.
  • Created AS-IS and TO-BE diagrams, gap analysis and stakeholder presentations to keep project team aligned to proposed changes to current requirements, processes and workflows.
  • Experienced with the PMO Gating processes (Analysis, Design, Execution, Implementation and Maintenance associated with System Life Cycle Development (SDLC) and Software Development Life Cycle.
  • Exceptional written, verbal and presentation skills and ability to understand, align and ensure integration of both IT and business solutions.
  • Experience working with managing vendor partners, suppliers, consultants, and contractors.
  • General understanding of laws, rules and regulations applicable to the Global Safety industry in US, Europe, Chinese and Japanese regulatory agencies.

Confidential, Blue Bell, PA

Senior Project Manager

Responsibilities:

  • Senior Project Manager on-boarded to lead effort to implement the PRA’s number priority Clinical Trial Management System on a Sales Force platform. Responsible for understanding legacy Clinical Trial Management System Payments Module and creating the strategy to migrate system features and functionality to the new Predictivv Study Operations (PSO) 3.0, Payments.
  • Had immediate impact on the project team that needed a better way to organize the requirements gathering, document the legacy functional requirements, build existing functional into new system and improve a mostly developed Customer Relations Management System that included Clinical Operations.
  • Quickly organized requirements from CTMAX -Payments and Clinical Trial Management System - Payments into the Team Foundation Server PSO Payment Module. Setup interviews with stakeholders and Subject Matter Experts and provided demos of the new functionality to assist Business Area users in understanding what the new system would look like and how they would benefit from the new Payments Module.
  • Lead effort to gather user requirements, setup WebEx meeting to demo the Payment application and organized the cross-functional teams that were geographically challenged by four different time zones across the globe.
  • Used experience and expertise in the validation, quality assurance, requirements gathering, documentation, and client support to gain the acceptance and trust of the team members to enable the project team to organize their efforts which quickly exceeded project timeline expectations.
  • In less than 2-months wrote 60 Business Requirements and over 300 user requirements. Used tools such as Excel to organize the requirements and get verification from Business User and then input all requirements and user stories into the Foundation Team Server.
  • Called upon by Quality Unit to assist the project team in setting up test strategies, participated in Agile team sessions, lead the planning sections and keep track of performance and delivery commitments.
  • Lead the Investigator Grants Management team in the identifying requirements for the new system and publishing the Payments User Requirements Specification. Kept the team focused on payment process as well identifying and documenting the pre-conditions and pre-requisites needed in other PSO module that were needed to may create payment requests and generate payments.

Confidential, East Hanover, NJ

Senior Business Analyst

Responsibilities:

  • Lead cross-functional clinical trial project team in the development of Business Cases, Use Cases, User Stories, Functional Requirements, Test Strategies, Business Process Development and data flow diagrams.
  • Create the high-level test strategy and create test cases for the testing and implementation of the new Novartis Trial Network Portal Document Library and Safety Notification.
  • Created the Clinical Operations, Drug & Safety Surveillance (ARGUS) business and identified business requirements
  • Worked closely with the vendors and Novartis associates to develop test cases, setup portal demonstrations and ensure all legacy data was migrated to the new system.
  • Lead the cross-functional effort to ensure the work stream teams aligned with the Corporate Information Technology initiatives to re-purpose legacy systems, retire systems no longer needed and implement new systems.
  • Created User Requirements Specification for the Document Library, Safety Notification, Clinical Administration, and Adaptive Trial Monitoring.
  • Received laudatory comments from Senior Managers for rapidly grasping the complex interdependencies of the systems, applications and portal and articulating to team clear objectives and management goals to meet project timelines.

Confidential, Greensboro, NC

Senior Project Manager

Responsibilities:

  • Led a top Global manufacturing company in developing and implementing Quality Management System, Master Control. Recognized ahead of peers for outstanding performance in Clinical, Laboratory and Manufacturing system implementations and major upgrades to regulated systems.
  • Due to a recent company merger was called upon to lead the effort in the implementation and validation of MasterControl.
  • Developed the Project Manager strategy to elicit business requirements, scope the timeline and deliverables, and create the process flows AS-IS and TO-BE for Quality Events Modules: Nonconformance, Corrective Action \ Preventative Action and Change Management.
  • Lead the effort to organize, facilitate and execute the 1:1 interview, consolidated group interviews and cross-functional team strategy meetings. Successfully developed and published the 1st AS-IS process flows for Nonconformance Report, Out of Specification, and Corrective Action\Preventative Action.

Confidential, Jersey City, NJ

Senior Project Manager

Responsibilities:

  • Developed and implemented the IUD product launch project plan and communicated the Go-Live preparation for Liletta Access Connect Web Portal launch.
  • Performed the Program Manager role for the entire product launch. Given the responsibility to quickly turn around a project that had a launch date that could not be moved back.
  • Took full ownership of the Business Analyst deliverables that included Business Requirements Document, Functional Requirement Specifications, Integration and Regression Test Plans, and User Acceptance Test Cases.
  • Received laudatory comments from Executive Team, Senior Managers, clients and co-workers for the outstanding problem resolution and an ability to keep the team focused on the critical path deliverables.

Confidential, Hampton, NJ

Senior Project Manager

Responsibilities:

  • Senior Project Manager for IT, R&D, Clinical Operations, Drug & Safety Surveillance (ARGUS) and Regulatory Operations. This role owned all matters related to IT validation and requires the project planning and oversight for multiple IT projects.
  • Organized the teams and implemented the data migration from Confidential ’s legacy systems to Bellerophon, the new company.
  • Saved the new company over $500,000 in IT cost by prioritizing business critical systems and eliminating redundant systems.
  • Created and managed the IT portfolio of over 100 business applications and clinical systems to ensure alignment with business goals and objectives.
  • Received laudatory comments from CEO and Executive Team for successful execution of these two-large scale and complex projects.

Confidential, Hampton, NJ

Senior Project Manager

Responsibilities:

  • Provided IT support to Clinical Operations, Manufacturing, Laboratory, and Quality Department. The Senior Manager creates the IT plan, manages the budget, implements the IT validation strategy, and owns the IT portfolio for R&D and Corporate Systems.
  • Revitalized the global IT division systems to harmonize data and make the systems capable of supporting the rapidly growing Device and Drug manufacturing’s $20 million portfolio.
  • Led validation teams in revitalizing IT processes, implementing cutting edge R&D systems and retiring non-business critical systems.
  • Created the GxP computer system validation functions that met 21 CFR Part 11, Part 58, Part 210, Part 211 and Part 820 requirements.
  • Successfully identified gaps in the vendor management procedures and revised the IT validation procurement steps resulting in cost savings exceeding more than $400,000 in multi-year maintenance contracts and support agreements.
  • Resolved licensing issues with multiple vendors to ensure the Confidential research spin-off company could continue to pursue their business objectives during the transition period.

Confidential, Summit, NJ

Senior Business Analyst

Responsibilities:

  • Led Business Area cross functional teams as Senior Business Analyst with hands on experience in Clinical, Medical Operations, Medical Information, Biostatistics, Data Management and Global Business Partners.
  • Provided leadership in Celgene’s System Delivery Life Cycle (SDLC) for the testing and implementation of Clinical systems worldwide.
  • Built the relationships and interfaced with Business Partners in Clinical Operations, Medical Affairs, Regulatory Operations, Biostatistics, Clinical Data Management, Quality and Safety to set up cross-functional and interfaced systems and applications.
  • Reduced testing windows for several major Celgene systems by leading the effort to stop re-testing functional requirements already done by the vendor for COTS products.
  • Established strong customer relationships to ensure effective and properly documented User Acceptance Test planning, test execution and reporting for Clinical, and Medical Operations

Confidential, Collegeville, PA

Director, Clinical Systems Development

Responsibilities:

  • Planned, designed, resourced and implemented the 1st Performance Qualification Team in a major Pharmaceutical Company that leveraged the skills of Business Analyst, Validation Specialist and Technical Writers to provide unparalleled support to Global Clinical Operations, Research and Development, Vaccines, Laboratory and Logistics.
  • Received the Company’s highest honor - Exceptional Achievement Recognition Award for Problem Solving Process Improvement.
  • Accepted the challenge of building an entirely new Department at a major global pharmaceutical company to address spiraling cost associated with bringing clinical systems to production.
  • Lead the Business Areas in identifying strategic requirements, developing budgets, planning the resources and implementing the processes to reduce the window to bring systems to production from 15 months to less than 6 months (on average).
  • Reduced the costly retesting and re-work of Clinical Systems by systematic analysis of requirements, capturing and prioritizing user requirements and queuing up like systems, application and reports into groups to make best use of limited resources and time.

Confidential, Collegeville, PA

Senior Business Analyst

Responsibilities:

  • Provided extensive clinical experience in software development, Functional, Integration, Regression, System Testing and UAT that provided the bridge between business areas and Information Technology.
  • Built technology roadmap for the 3-5-year clinical systems. Identified the business strategies, and challenges.
  • Used extensive knowledge of regulatory standards of FDA - GxPs (GMP, GLP, GCP), 21 CFR Part 11 and Computer Systems Validation.
  • Analyzed End-User and system requirements and created test scenario's that resulted in fewer re-test cycles and ultimately reduced project timelines by greater than 30%.

Hire Now