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    Clinical Trial Project Management

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    rahil_khan797
    The document discusses the fundamentals of project management. It defines project management as applying knowledge and skills to meet stakeholder needs and expectations on a clinical trial project. It outlines the typical project phases of initiation, planning, execution and control, and closeout. The initiation phase involves defining objectives, requirements, and solutions. The planning phase develops the project plan. The execution phase implements the plan and controls performance. Closeout completes the project upon deliverable acceptance. The role of a project manager at a CRO is to lead the team, communicate with clients, manage changes, and represent the project internally.

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    Download as PPT, PDF, TXT or read online from Scribd

    Clinical Trial Project Management

    Uploaded by

    rahil_khan797
    2K views13 pages
    The document discusses the fundamentals of project management. It defines project management as applying knowledge and skills to meet stakeholder needs and expectations on a clinical trial project. It outlines the typical project phases of initiation, planning, execution and control, and closeout. The initiation phase involves defining objectives, requirements, and solutions. The planning phase develops the project plan. The execution phase implements the plan and controls performance. Closeout completes the project upon deliverable acceptance. The role of a project manager at a CRO is to lead the team, communicate with clients, manage changes, and represent the project internally.

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    The document discusses the fundamentals of project management. It defines project management as applying knowledge and skills to meet stakeholder needs and expectations on a clinical trial project. It outlines the typical project phases of initiation, planning, execution and control, and closeout. The initiation phase involves defining objectives, requirements, and solutions. The planning phase develops the project plan. The execution phase implements the plan and controls performance. Closeout completes the project upon deliverable acceptance. The role of a project manager at a CRO is to lead the team, communicate with clients, manage changes, and represent the project internally.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    2K views13 pages

    Clinical Trial Project Management

    Uploaded by

    rahil_khan797
    The document discusses the fundamentals of project management. It defines project management as applying knowledge and skills to meet stakeholder needs and expectations on a clinical trial project. It outlines the typical project phases of initiation, planning, execution and control, and closeout. The initiation phase involves defining objectives, requirements, and solutions. The planning phase develops the project plan. The execution phase implements the plan and controls performance. Closeout completes the project upon deliverable acceptance. The role of a project manager at a CRO is to lead the team, communicate with clients, manage changes, and represent the project internally.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 13

    Rahil Khan ICRI

    Definitions
    the application of knowledge, skills, tools,and

    techniques to project activities in order to meet or exceed the stakeholders needs and expectations from a project Inn the clinical research setting, a the clinical research setting, a project is a unique clinical trial. It has a discrete start date and end date. Within a CRO, project management can be interpreted as delight the client, support the project team, and delight seni management.

    PM Fundamentals
    What are Project Phases?
    1.

    Initiation
    Define projects objective

    2.

    Planning
    Detail who does what when

    3.

    Execution and Control


    Actual work occurs Compare performance to plan, make corrections

    4.

    Closeout
    Projects deliverables are accepted

    PM Fundamentals
    Initiation Phase
    1. 2.

    3.

    Describe the characteristics of the product or service expected from the project. Analyze the projects requirements, identify potential solutions, determine the technical and economic feasibility of each, compare and select the best solution. Develop the project proposal What is to be done Why is it to be done How is it to be done How much risk is involved

    PM Fundamentals
    4.

    Approve the project


    Based on the ROI (Return On Investment) of cost, resources, time

    5.

    Select a Project Manager


    Responsible for managing all aspects of the project

    Output of Initiation Phase Project Charter

    PM Fundamentals
    Planning Phase 1. Define an orderly arrangement of activities and resources to deliver the product or service. 2. Begin by outlining all tasks (the work) 3. Identify the resources (people, hardware, software, services, etc.) required for all tasks 4. Organize the tasks into sequences of chronological events (schedule) 5. Develop a spending plan within the budget

    PM Fundamentals
    5. 6.

    7.

    Arrange to procure external resources Identify all stakeholders and the method (how), frequency (how often), and content (what) of communications to them Analyze risks and decide what can be done about them

    Accept, Mitigate, or Transfer

    8.

    Determine how to measure success Output of Planning Phase Project Plan

    PM Fundamentals

    1. 2. 3. 4. 5. 6.

    Depending on complexity, project plans can contain:


    Work Breakdown Structure Resource Breakdown Structure Schedule Budget and Spending Plans Performance Plan Risk Management Plan

    PM Fundamentals
    7. 8. 9. 10. 11.

    Procurement Plan Communications Plan Change and Configuration Management Plan Quality Management Test Plan Quality Management IV&V Plan

    The Project Plan is used to guide project execution and project control.

    PM Fundamentals
    Execution and Control Phase Execution of the Project Plan is the act of performing tasks and activities that result in the production of project deliverables. Performance must be monitored against the plan

    Schedule Deviation Cost Overruns Project Issues Change Requests

    PM Fundamentals
    Project Managers produce regular Status Reports for

    key stakeholders Not meeting scheduled dates, exceeding spending plans, unresolved issues and requests for changes should be reported to stakeholders and addressed immediately Outputs of Execution and Control Phase are the Project Deliverables.

    PM Fundamentals

    Closeout Phase Closeout occurs when the sponsor accepts the project deliverables and the projects oversight authority concludes the project has met all goals New systems are turned over to operations, project documentation is archived, lessons learned are cataloged, any staff and resources are returned
    Output of Closeout Phase is User Acceptance

    The Role of a Project Manager in a CRO


    Project team leader Primary point of contact for team and client Client advocate within the CRO Manager of project change Internal business development representative

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