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Project Manager Resume

Rockville, MD

SKILLS:

  • Experience gathering, documenting, and establishing requirements traceability using requirements traceability tools.
  • Experience with developing use cases and test case scenarios
  • Experience with providing consulting services in the area of Medicaid and health insurance.
  • Experience with managing projects that used the software development life cycle (SDLC)
  • Experience with project plans and work breakdown structures (WBS) for software development IT projects
  • Information technology project management experience
  • Knowledge of Medicaid or commercial insurance
  • Vendor/contract oversight experience
  • Experience working with and/or knowledge of the System for Electronic Rate

EMPLOYMENT HISTORY:

Confidential

Project Manager

Responsibilities:

  • In consultation with appropriate stakeholders, prepare and manage project plan in accordance with Project Management Institute’s project management standards as well as the Project Management Office standards.
  • Work with the various BCHD school health personnel and document, verify and get approved all the project requirements, screens, data fields, variables, descriptions, calculations, reports, work flow and other development needs of the project.
  • Use a web - based project management environment to document all project plans, milestones as well as all project related documentation.
  • Proven expertise in gathering, analyzing and documenting business requirements and developing BRD, FRD and helped in preparing SRS.
  • Accountable for Functional Requirements, Specifications, and Traceability.
  • Manage procurement and deployment of PCs and peripherals to all locations.
  • Experience in managing projects deliveries through full software development life cycle (SDLC).
  • Provided Consulting services in Medicaid and Health Insurance.
  • Coordinate and manage the training and activation of all users.
  • Communicated the team and Project manager with Project plan and Work Break down Structure (WBS) to reduce time, resource and cost and to improve quality of the IT Project.
  • Coordinate work and interface with BCHD and BCPSS personnel as needed.
  • Keep track of and resolve issues and problems.
  • Worked on Healthcare system implementation including enterprise Electronic Medical Records (EMR) and Electronic Health Records (EHR) software and Electronic Rate System.
  • Created Use case, Test Plan, Test Cases and performed Testing for all the user scenarios.
  • Identify and manage project risks.
  • Experience in consulting services with user and vendors oversight for need assessment.
  • Provide reports and maintain appropriate communications with all stakeholders.
  • Work with stakeholders to develop access control and data integrity and quality needs and work with system administrators to implement and monitor the solutions.
  • Maintain workload statistics, prepare narrative and statistical reports accounting for activities and maintain database and system documentation.
  • Successfully implement School EHR project within agreed upon schedule and budget.
  • Maintain regular communications with all stakeholders and ensure that all stakeholders are able to see real-time project status at any time using a web-browser.

Environment: Software Development Life Cycle experience: Functional Requirements Analysis; Modules Design; Prototyping; Test Plan, Pilot Modules; Customization; Debugging; Training and Implementation Privacy & Security, FERPA and HIPPA Confidentiality Compliances.

Confidential, Rockville, MD

Senior Project Manager

Responsibilities:

  • Drove cross-functional, operational integration for the Vaccine PDT, including coordinating cross-functional activities and communications involving team members and Global Partners with minimal supervision.
  • Coordinated the creation and maintenance of the integrated Vaccine Product Development Plan and timeline.
  • Managed projects deliveries through all Phases of software development life cycle (SDLC).
  • Ensured linkage between strategy and operational activities.
  • Identified issues and facilitated problem-solving, contingency planning, and decision-making.
  • Proven expertise in gathering, analyzing and documenting business requirements and developing BRD, FRD and helped in preparing SRS.
  • Accountable for Functional Requirements, Specifications, and Traceability.
  • Experience in consulting services with user and vendors oversight for need assessment.
  • Informed key stakeholders of status, issues, problems, and proposed solutions as appropriate.
  • Created Use case, Test Plan, Test Cases and performed Testing for all the user scenarios.
  • Assumed full responsibility for managing specific aspects of the project as designated by team leadership.
  • Partnered with various international team leaders to foster effective team dynamics.
  • Provided performance feedback to team and cross-functional line management on Vaccine PDT members.

Project Timeline, Resource, and Cost Management:

  • Collaborated with cross-functional team members to support the Vaccine PDT's strategy and execution of deliverables.
  • Worked with the Vaccine PDT to develop, maintain, and align an accurate, integrated project timeline, resource plan, and budget.
  • Understood critical path activities, anticipated risks, and created contingency plans in collaboration with project teams.
  • Generated timeline, resource, and budget information that facilitate scenario planning, contingency planning, risk assessment and management, problem-solving, and decision-making.
  • Communicated the team and Project manager with Project plan and Work Break down Structure (WBS) to reduce time, resource and cost and to improve quality of the IT Project.
  • Monitored and managed team performance metrics relative to agreed upon project plan.
  • Coordinated interactions with corporate governance bodies to ensure programs have adequate budget and resources to support approved scope.
  • Identified deviations from PDC-approved project plans and timelines and informed the PDT as to their nature and extent.
  • Negotiated with team members to establish new timelines aligned with corporate goals
  • Applied Project Management Methodologies to execute and monitor work packages

Environment: EU Regulatory experience: EMEA, OCABAR

Confidential, Easton, MD

Product/Project Manager

Responsibilities:

New Product Analysis:

  • Worked with Manufacturing, Engineering, Purchasing, QA and the Laboratory to determine feasibility of new product or product modification.
  • Developed Phase 1 and Phase II costs for products deemed feasible
  • Coordinated the production of samples.
  • Created Use case, Test Plan, Test Cases and performed Testing for all the user scenarios.
  • Coordinated the performance of PSPs if required to determine feasibility.
  • Worked on Healthcare system implementation including enterprise Electronic Medical Records (EMR) and Electronic Health Records (EHR) software and Electronic Rate System.
  • Accountable for Functional Requirements, Specifications, and Traceability.
  • Proven expertise in gathering, analyzing and documenting business requirements and developing BRD, FRD and helped in preparing SRS.
  • Conducted CapEx return on investment analyses as needed

Project Management:

  • Managed/Coordinated all project management activities related to new products and existing product re-design in a matrix environment
  • Scheduled and lead project team meetings to ensure timely execution of action items.
  • Managed projects deliveries through all Phases of software development life cycle (SDLC).
  • Worked with other departments to ensure that sufficient resources are available for timely execution of projects.
  • Experience in consulting services with user and vendors oversight for need assessment.
  • Communicated the team and Project manager with Project plan and Work Break down Structure (WBS) to reduce time, resource and cost and to improve quality of the IT Project.
  • Provided Consulting services in Medicaid and Health Insurance.
  • Coordinated stability runs for FDA and other regulated products in concert with Regulatory & Quality department
  • Reviewed, negotiated, documented and controlled all customer supplied specifications
  • Assured compliance to regulatory document control requirements
  • Implemented CAPA to enforce quality and standard specifications

Total Cost Productivity:

  • Reviewed and updated cost baseline
  • Worked with Purchasing, Manufacturing, and Engineering to drive specific targeted cost reduction projects

New/Modified Product Launches:

  • Assisted in Developing timely and accurate Product and Batch Master Records
  • Ensured that all aspect of Design Control are completed as appropriate
  • Ensured that IQ/OQ/PQ and PVs are performed as required on new or modified processes.

Environment: USFDA 21 CFR 210 & 211 - GMP, USFDA 21 CFR part II & 58 GLP USFDA DOH & HS 21 CFR 210/211, USEPA 40 CFR part 160 & 792, ISO 9001 & 13845 Medical Device

Confidential, Corvallis OR.

Project Manager

Responsibilities:

  • Managed candidate selection and preclinical assessments of drug development
  • Developed and managed timeline
  • Identified inadequacies in development plan
  • Developed project contingency plan
  • Revised Performance Schedule as needed and appropriate
  • Involved in all Phases of software development life cycle (SDLC).
  • Communicated the team and Project manager with Project plan and Work Break down Structure (WBS) to reduce time, resource and cost and to improve quality of the IT Project.
  • Proven expertise in gathering, analyzing and documenting business requirements and developing BRD, FRD and helped in preparing SRS.
  • Developed Test Plans, Test Cases along with RTM (Requirement Traceability Matrix).
  • Managed, organized and documented team meetings at appropriate development stage
  • Generated monthly progress report, accomplishments and disappointments.
  • Created Use case, Test Plan, Test Cases and performed Testing for all the user scenarios.
  • Communicated project issues with the management and generated action plans
  • Provided general support for product development
  • Defined objectives, assumptions and constraints of the project
  • Determined the project tasks and organized the tasks into milestone
  • Estimated resources need, task durations and created relationships between tasks
  • Managed vendors: participated in vendors technical performance evaluation, RFP, RFQ and selection processes
  • Set up methods for communicating with the project team and kept the project up to date

Confidential, Frederick, MD

Project Manager

Responsibilities:

  • Coordinated training and enforced adherence to updated process improvement
  • Mentored, coached and prepared team members to achieve unit goals
  • Managed all resources and tasks in an efficient manner, including collaboration with other members of the SeraCare Management team to achieve common goals and objectives
  • Participated in all repository operations, including communication, coordination and prioritization of activities as appropriate.
  • Reviewed and approved all documentation associated with projects
  • Coordinated and conducted investigation to resolve data discrepancies and communicate with the clients.
  • Experience in consulting services with user and vendors oversight for need assessment.
  • Provided Consulting services in Medicaid and Health Insurance.
  • Communicated the team and Project manager with Project plan and Work Break down Structure (WBS) to reduce time, resource and cost and to improve quality of the IT Project.
  • Managed projects deliveries through all Phases of software development life cycle (SDLC).
  • Monitored project expenses and ensure that project is monetarily on track
  • Enforced GMP/GLP/GDP/ISO regulations and standards as applies to the group.
  • Supervised and managed staff in keeping with objectives and corporate culture.
  • Communicated with clients and collaborators with regard to data management, specimens tracking both internally and externally
  • Assisted clients, collaborators and senior management in the implementation of new studies and protocols
  • Prepared reports and correspondence to clients and collaborators and department directors
  • Made recommendations on new business opportunities as appropriate
  • Assisted in bidding on new projects, writing proposals, and preparing budgets
  • Assisted in the development and implementation of new repository projects
  • Kept current on IATA shipping regulations and maintain certification and standards
  • Implemented CAPA to enforce quality and standard specifications

Environment: Quality Standard experience: GLP, GxP

Confidential, Vienna VA

Project Leader

Responsibilities:

  • Served as a team member on toxicology studies in primates and small animals
  • Kept current on IATA shipping regulations and maintain certification and standards
  • Ensured quality control procedures are carried out according to SOPs
  • Provided clinical study management and assure overall successful conduct of assigned clinical studies consistent with applicable guidelines
  • Worked on Healthcare system implementation including enterprise Electronic Medical Records (EMR) and Electronic Health Records (EHR) software and Electronic Rate System.
  • Interfaced with representatives from key functional groups; Analytical Chemistry, Clinical Pathology, Report Coordination, and Study Direction.
  • Involved in all Phases of software development life cycle (SDLC).
  • Provided Consulting services in Medicaid and Health Insurance.
  • Collaborated with other departments to coordinate clients site visits and activities with study needs
  • Prepared diets, gavages, intravenous and capsules with test materials and vehicles according to the established protocols and SOPs.
  • Prepared study-related documentation from initiation to completion of a study.
  • Responsible for QA audits and clients study-related inquiries
  • Implemented CAPA to enforce quality and standard specifications
  • Maintained and achieved study raw data/materials as outlined under GLP/cGMP requirements
  • Responsible for DEA Controlled-Materials that are assigned to a specific study as established in the company SOP
  • Mentored team members and coordinated Process Improvement Plan
  • Six-Sigma member

Environment: USFDA 21 CFR 210 & 211 - GMP, USFDA 21 CFR part II & 58 GLP USFDA DOH & HS 21 CFR 210/211, USEPA 40 CFR part 160 & 792. CAPA, Root-Cause Analysis, Six-SigmaPREVIOUS PROFESSIONAL EXPERIENCE:Confidential, Manassas, VA

Biologist and Business Development Coordinator/TSR

Responsibilities:

  • Acted as a liaison between ATCC scientific collections and the scientific community
  • Propagated and authenticated microbial strains for Research and Development.
  • Involved in all Phases of software development life cycle (SDLC).
  • Managed various contracts for pharma, biotech, academia and research institutions
  • Provided customers with technical data on biological materials and information on product patenting and regulatory issues
  • Worked collaboratively with software developers to communicate website development
  • Planned, prepared, edited, wrote and disseminated newsletters, articles, and other collateral pieces
  • Assisted customers in the proper selection of biological materials
  • Supported pre- and post-sales technical inquiries
  • Interacted with scientific staff and product managers to increase technical service competency and customer satisfaction.

Environment: Quality Standard experience: ISO 9000 Series, GxP, QMS

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