Project Management

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Contracts
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A mutually binding agreement which obligates the performing organization (seller) to provide the specified services/products and obligates the Sponsor (buyer) to pay for them.
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Constraints
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Factors that limit the team’s options such as limits on resources, budget, schedule and scope. Ex. Sponsor-mandated timelines, inadequate budget, difficult patient population, complex protocol, inexperienced team members, team turn over, ect.
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The Triple Constraint
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Cost= function of (Quality, Time Schedule, Project Scope)
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Expanded Triple Constraint
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Time, Cost, Scope, Quality, Customer Satisfaction, Risk
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Control
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The process of comparing actual performance with planned performance on a project, analyzing variances, assessing trends and taking appropriate corrective action.
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Cost Estimating
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Estimating the cost of resources (people(labor), equipment, and materials) needed to complete project activities.
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Critical Path
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In a project network diagram, the critical path is the group of project activities which takes the most time to complete. Delay in any activity on the critical path will cause a delay in end date of the project activities.
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Deliverable
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Any measurable, verifiable, outcome, result, or item that must be produced to complete a project.
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Fast Tracking
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Compressing a project schedule by doing tasks in parallel that would normally be done in sequence.
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Gantt (Baar) Chart
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A graphic display of project schedule-related information. activities or other project elements are listed down the left side of the chart, dates are shown across the top, and activity durations are shown as horizontal bars.
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Program
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A group of related projects managed in a coordinated way to obtain benefits and control not available from managing them individually.
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Project
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A temporary endeavor undertaken to create a unique product, service, or result with a definite beginning and end. A series of activities designed to deliver something of value to your customer.
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Clinical Research Project
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A temporary endeavor undertaken to discover new information, or verify existing information about clinical efficacy and/or safety of a drug.
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Project vs. Operations
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-Projects are temporary endeavors undertaken to produce a unique product or service. -Operations are repetitive/ongoing activities that produce the goods or services of an organization. -Most organizations use a combination of “projects” and “operations” to accomplish their goals.
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Project Charter
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A document issued by the project sponsor or an organization’s upper management that formally authorizes the existence of a project, and provides the project manager with the authority to apply organizational resources to project activities. -contract/agreement with sponsor may serve as project charter
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Project Charter Elements
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-What, who, why, business case justification/ROI -Project Titles and Description (what is the project?) -Project Manager Assigned (who is given authority to lead the project team?) -Business Need (Why is the project being done?) -Project Justification (business case justification/Return on Investment (ROI))
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Project Communications Management
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A subset of project management that includes the process required to ensure timely and appropriate generation, collection, distribution, storage, retrieval and final disposition of project. It consists of COMMUNICATION PLANNING, INFORMATION DISTRIBUTION, PERFORMANCE REPORTING, AND ADMINISTRATIVE CLOSURE.
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Project Cost Management
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A subset of project management that includes the processes required to ensure that the project is completed within the approved budget. It consists of RESOURCE PLANNING, COST ESTIMATING, COST BUDGETING, and COST CONTROL.
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Project Human Resource Management
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A subset of project management that includes the processes required to organize and manage the project team. It consists of human resource planning, acquire project team, develop project team and manage project team.
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Project Life Cycle
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A collection of generally sequential project phases whose name and number are determined by the control needs of the organization or organizations involved in the project. INITIATING, PLANNING, EXECUTION, CONTROLLING, CLOSEOUT
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Project Initiation
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Authorizing the project or phase -Draft (outline) scope of work available, Project manager assigned -Define goals for project -Market/stakeholder analysis -Strategize -Identify success criteria for the project -Write Project Charter and get approved -Develop preliminary project SOW
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Project Planning
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Defining project objectives and selecting the best approach to attain them -Scope of work complete, project team assigned and trained, project plan complete and approved
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The “Core Project Planning Process” steps create the
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Project Plan
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Project Management Plan
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A formal, approved document that defines how the project is executed, monitored and controlled. It may be summary or detailed and may be composed of one or more subsidiary management plans and other planning documents.
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Project Plan Contents
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-Project Charter (Contract) -Project SOW -WBS -Detailed Budget -Performance measurements baselines for schedule and costs -Timelines with major milestones -Project Organizational chart and Team list -Risk, Quality, and Scope Management Plans -Plans from other departments, services, ect -Open issues and pending decisions
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Project Planning (iterative process)
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Planning is an iterative process that involves listing all activities required in a project, and preparing an estimate of the resources, budget, and time necessary to complete them.
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Good Planning vs Bad Planning
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Good planning is a pain in the beginning, but decreases pain over all, especially in the end. Bad planning exponentially increases pain at towards the end of the project.
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Project Execution
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Coordinating people and other resources to carry out the plans for the project -All project tasks conducted and deliverables produced -Most activity, longest duration
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Project Controlling Processess
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Ensuring that project objectives are met by monitoring and measuring progress regularly to identify variances and taking corrective action as necessary -Periodic measurements of progress vs. plan; corrective actions taken as necessary to make “actuals” match “predicted”
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Project Close-out
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Formal acceptance of deliverables, closing the project, and archiving records
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Project Milestone
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End of a project phase. -Significant events in the project -Major interfaces between project phases -Provide feedback to the project team and other stakeholders on overall project progress -Lessons learned/accomplishment recognition -Project reviews and Go/No Go decisions
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Project Management
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The application of knowledge, skills, tools, and techniques to project activities to meet the project requirements. PEOPLE, TOOLS, AND SYSTEMS
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Effective PM Requirements
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-Be familiar with and use PM processes as outlined in PMI’s PMBOK -Know the project area, standards, and regulations -Understand the project environment -Employ general management knowledge and skills -Possess and use effective interpersonal/communication skills
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Why use Project Management?
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Limited resources, manage changes, complex projects produce significant challenges, evolving processes and technology, changing/increasing customers’ expectations
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PMBOK
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Project Management Body of Knowledge An international standard published by the Project Management Institute. An inclusive term that describes the sum of knowledge within the profession of project management.
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Project Management Software
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A class of computer applications specifically designed to aid the project management team with planning, managing and controlling the project, including costs, schedules and resources. -used to create Gantt charts and major milestone schedule
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Project Manger
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The individual who is primarily responsible for managing a project. Primary Responsibility: Deliver the project on time, on budget, and with the quality specified in the Scope of Work.
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Project Manager Responsibilities
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Primary Responsibility: Deliver the project on time, on budget, and with the quality specified in the Scope of Work. Other Responsibilities: lead project planning and execution, define team roles/responsibilities, communication, risk management, issue resolution, team turnover management, project tracking and status reporting to all stakeholders, manage scope of work, training, lessons learned meetings, perform proper close-out
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PLINC
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Essential skills of the PM. Problem Solving Leadership and motivating the team Influencing the Organization Negotiating and Conflict Management effective Communication
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Project Phase
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A collection of logically related project activities, usually resulting in completion of a major DELIVERABLE.
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Project Plan
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A formal, approved document that defines how the project is executed, monitored and controlled. It may be summary or detailed and may be composed of one or more subsidiary management plans and other planning documents.
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Project Plan Execution
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Carrying out the project plan by performing the activities included in the project plan.
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Project Procurement Management
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A subset of project management that includes the processes required to purchase or acquire the products, services, or results needed from outside the performing organization to perform the project work.
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Scope
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The sum of all work that must be performed to deliver a product, service, or result that includes all of the specified features and functions on the project. -SOW developed during project initiation and planning phases -Outlines goals/deliverables -Describes success criteria (requirements/specifics on obtaining deliverables) -Lists assumptions and constraints -Contains “high-level” timelines -Essential document in the Project Plan
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SOW contains
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-written description of the project requriments -Responsibilities of the Buyer (customer) and Seller (contractor) -Assumptions and constraints -Technical or performance specifications -Deliverables and acceptance criteria -High level schedule and milestones -Project budget and payment schedule -Scope change process -Communication and reporting requirements
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SOW when properly written, details:
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What you plan to do, who is going to do it, how much it will cost, how you will know when you are done
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Project Quality Mangaement
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A subset of project management that includes the processes and activities required to ensure that the project will satisfy the needs for which it was undertaken.
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Project Risk Management
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A subset of project management that includes the processes concerned with planning, identifying, analyzing, responding, and controlling project risk.
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Project Schedule
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The planned dates for performing activities and the planned dates for meeting project milestones.
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Project Team Members
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The people who report either directly or indirectly to the project manager on a project.
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Project Scope Management
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A subset of project management that includes the processes required to ensure that the project includes all of the work required, and only the work required, to complete the project successfully.
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Scope Change Control
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Controlling changes to project scope.
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Stakeholder
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Individuals and organizations who are involved in, or whose interests may be affected positively or negatively by project activities. This can include the PM, Project Team Members, Company Executives, sub-contractors, ect. at both the Sponsor and performing organization, as well as the public.
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Work Breakdown Structure
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A deliverable-oriented hierarchical grouping or list of work to be executed by the project team, to accomplish the project objectives and create the required deliverables. It organizes and defines the total scope of the project. “road-map” for projects.
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WBS Attributes
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Organizes and defines the scope of the project, breaks down the project into smaller more manageable pieces, each level of the WBS is a smaller piece of the level above, at the lowest level of the WBS, a deliverable or project work component is segmented into work packages, includes both internal and external deliverables -identifies project deliverables, tasks, resources, framework, team members assigned, costs, used to build PND and schedule, , helps identify risk
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WBS Formats
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Indented (paragraph) Graphical or Tree Structure
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WBS as a Valuable Project Tool
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“Thought Process Tool” “Architectural Design Tool” “A Planning Tool” “A Project Status Reporting Tool”
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WBS as a “Thought Process Tool”
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A design and planning tool that helps the project team visualize the project.
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WBS as an “Architectural Design Tool”
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A graphic of the project work and how activities relate to one another.
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WBS as a “Planning Tool”
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A detailed representation of all project activities. Allows project team to estimate activities durations, resource requirements and build the project schedule.
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WBS as a “Project Status Reporting Tool”
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Completed activities can be “rolled-up” (consolidated) to demonstrate progress on deliverables and project milestones.
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WBS Applications
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-to develop the project budget, plan resourcing and build the project schedule -shows inter-relationships between project activities conducted by all groups involved -can be used to train new team members and show them how their job fits in the overall project -to identify all project deliverables and who is responsible for them -provides an excellent way for the project team to identify project risks
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Benefits of Using a WBS
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-identifies specific work packages required to estimate work and build the project budget -forces detailed planning documentation, and facilitates resourcing for project -improves work assignments for project team members and helps them understand how they fit into the overall project -helps team members prepare more accurate project schedules and identify project risks -FOCUSES TEAM’S ATTENTION ON PROJECT DELIVERABLES
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Work packages
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A deliverable or work component at the lowest level of each branch of the WBS. -Basis for all project planning
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Work Package Attributes
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Work cannot logically be subdivided further, resources to completed can be effectively estimated, can be completed quickly with definite outcome/deliverable, can be outsourced/contracted out.
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Key to successful drug development programs
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Effective project management and successful project execution
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Linear Processes
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Drug Development, Project Lifecycle
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To execute the SOW effectively,
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the PM must carefully manage Customer/Sponsor “wants” vs “needs”
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Project Stakeholders
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Individuals and organizations actively involved in the project, or whose interests may be positively or negatively effected by the project.
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Key Stakeholders
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-Sponsor/Customer -Project Team -Performing Organization -Shareholders of Sponsor/Company/ and Performing Organization -Suppliers and subcontractors -Government agencies -Users of products resulting from the project (patients)
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Project Network Diagram
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A graphic representation of how project activities (tasks) in a WBS are inter-related. -identifies the activity (task) sequences, their durations, and critical path -allows team to develop project schedule -can serve as a useful tool for the project team to predict where potential problems may occur (risk identification) -valuable tool to teach new team members how project activities/tasks inter-relate
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Developing the PND
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1.) What activities/tasks must be done first? 2.) What activitites/tasks must be done next? 3.) What activities/tasks can be done in parallel? *The PND helps identify all places where activities/tasks can be done in parallel, thus allowing the team to create the shortest possible schedule/timelines
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Task Relationships
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Tasks require input and generate output, usually output from one task becomes input of the next, usually a logical relationship between tasks. The predecessor becomes the successor
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Finish to Start
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When A finishes, B may start.
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Finish to Finish
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When A finishes, B may finish
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Start to Start
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When A starts, B may start
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Critical path
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A series of activities that determine the duration of the project. “The longest path through a PND” (longest total time and minimum time required to complete project) -activities has zero float “slack” -Delay of any task on the critical path will effect project timelines
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Milestones
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significant project events -represent a single point in time (no duration) -Major interfaces between phases -Typically are on project critical path -Project may not be able to progress until timeline is reached -Enable progress reporting when achieved -Provide a good event for team to celebrate and discuss progress
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Crashing
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Attempting to decrease the total project duration by adding resources to activities on the critical path. -almost always increases costs and risks!
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Project Planning Process
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Identify and define activities required to produce deliverables specified in the SOW and outlined in the WBS
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Sequence Project Activities
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-Place activities in proper order of execution -Identify all dependencies between activities -Produce the Project Network Diagram
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Estimating duration of tasks
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depends on complexity, skill/experience level. Use historical information from similar projects to increase accuracy. Use “experts” who have done similar work to check your project team’s estimates of activity durations.
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PERT Weighted Average
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used to estimate task durations. [Optimistic time + (4x Most likely)+Pessimistic]/ 6
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Activity duration estimates improve as the project proceeds because
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more information becomes available, the project team become more familiar with procedures and teamwork develops, performance of participating organizations (eg. investigative sites) becomes more predictable
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Developing the Project Schedule
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Use project WBS and PND to identify tasks and sequence, then assign durations. Draft a schedule on paper and check it with team and experts before you enter all tasks into the project planning software.
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Goldratt’s Principle
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A project will accumulate delays but will never accumulate gains.
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Selecting Project Team
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The project manager should be very involved in selecting the project team whenever possible -Project Manager MUST be involved in building the Project TEam
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Steps to Team Assignment
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1. Identify people through HR planning 2. Obtain the people (acquire project team) 3. Develop the people (develop project team) 4. Manage the people (manage project team)
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Identify the people
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Determine project staffing needs. Specify team member skills, experience, and when proposed staff are needed on your project. Write roles and responsibilities for all team members. Develop proposed Team organizational chart.
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Obtain the people
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-Use list of required skills, experience and time commitments for team members to request resources. -negotiate to get the right people assigned -develop a training program to prepare team members to execute thier roles and responsibilites -Develop organizational chart and team directory and distribute to team, line managers, and sponsor
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Develop the people
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-schedule kick-off meeting to orient the team to the project, include building activities to build team identity and synergy -perform project specific training and ensure that all team members understand thier roles and responsibilities -Create a “reward system” to promote quality work -monitor team member performance and celebrate team accomplishments throughout the project
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Manage the people
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-Become deeply involved in project operations to effectively observe and assess team performance -Encourage innovation within the constraints of SOPS and other regulations -Manage team conflict productively always looking for “win/win” situations -Maintian an “issue log” wiht recommended corrective and preventative actions -Document all changes to the Project Management Plan and “lessons learned” -Provide input to team members performance appraisals to line managers
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Project resource planning
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plan for resource requirements over project duration, request resources to match when they will be needed
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Resource Histogram
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A vertical bar chart that shows the total number of resources needed during each phase/time period of the project.
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Biostatistician
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-involved in study design (sample size, protocol, ect) -assists in formulating research questions -determines appropriate sampling techniques -Coordinates with data management on data collection procedures -Carries out statistical analysis and interpretation on data obtained form the proposed research question
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Clinical Project Assistant
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-assists team to ensure customer service, quality and timelines -perform quality control checks to ensure the integrity of data -aid in the preparation of supply shipments to study sites -setup, maintain, and update databases -query resolution -file study documents
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Project Budget
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A summary of the anticipated costs (Labor and Expenses) of undertaking a project based on the Scope of Work
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Labor
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the personnel costs required to execute the project
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Labor costs
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Team member billing rate x hours charged to project
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Billing rates include
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Salary and benefits plus overhead (operating expenses, wages of non-billable staff, ect)
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Pass-through costs
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project expenses which are passed through at cost to the sponsor via invoicing (eg. travel costs for monitoring visits, investigator meeting costs, ect)
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Percent Complete
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A measure of a projects progress toward completion or “Earned Value” -calculated by dividing total units of a deliverable into the number of units currently complete
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Estimate to Complete
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Labor costs and expenses required to complete a project form the current date until the end of the project
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Estimate at Completion (EAC)
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An estimate of the total costs (labor and expenses) that will be incurred on the project to bring it to 100% completion. This is the sum of the actual costs to date plus the projected costs of any remaining work.
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Cost vs. Price
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Price is the amount an organization charges for a product or service Cost is how much it actually costs the organization to produce a product or perform a service
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Cost Management 4 stages
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1. Resource Planning 2. Cost Estimating 3. Cost Budgeting 4. Cost Control
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1. Resource Planning
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use WBS to determine what resources (types and quantity) are needed to complete each scheduled activity on a project (“Activity Resource Estimating”) ie labor, materials, skilll personnell
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2. Cost Estimating
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Developing estimated costs for resources needed [people (labor), materials/supplies and equipment] to complete the project
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Labor cost estimating
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use: project wbs, resource requirements, resource rates, activity durations, projected total labor costs
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Expenses cost estimimating
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use project wbs and scope of work
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Bottom Up Cost Estimating
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Estimating costs of individual project tasks/activities or work packages, including required materials, equipement, contracts, ect. and summing them to determine total project cost estimating
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Top Down Cost Estimating
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Using total costs of similar projects to estimate the cost of the new project
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Cost Estimating Procedures
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To estimate the duration/cost of tasks on project use PERT method, (O +4ML+ P)/6
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Parametric estimating
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uses statistical relationship between historical data and other variable cost estimate for an activity
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Three-Point estimates
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accuracy can be improved by considering the amount of risk in the original estimate, uses the average of three estimate durations. The average will often provide a more accurate activity duration that a single point, most likely estimate
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Project cost types
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Direct costs and indirect costs
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Direct costs
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costs directly attributed to work on a specific project (ie resources needed to conduct a project) Labor materials, equipment, contracts for services
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Indirect costs
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an organizations overhead (cost of doing business) ie taxes, insurance, rent, utilities, labor, and fringe benefits for supporting staff, ect.
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3. Cost Budgeting
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Allocating costs to individual project activities/tasks and materials to develop a baseline budget
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The project cost baseline is
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a time-phased budget that serves as the standard against which actual budget performace is compared against Projected Costs -Develop the Project Cost Baseline by using th eWBS, cost estimates, and schedule -must be chaged when scop is modified
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Cost Estimating Hints
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To produce accurate project cost estimates, use the WBS, historical records, and have experienced staff familiar with similar work to prepare the cost estimates
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4. Cost Control
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Controlling project costs and influencing factors that create variances and controlling budget changes during the project life cycle
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Cost Control involves
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-monitoring cost performance to detect and understand variances form cost baseline -ensuring all change orders are recorded in the project budget (cost baseline) -reduce expected costs overruns within acceptable limits -preventing unapproved changes to the project budget -informing project stake holders of changes to the project budget
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Managing Project Costs
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Review project budget with team members during project start up (repeat), translate budget into number of days/hours allocated to complete each task/activity, review projected vs actual time expended to complete project tasks regularly with team members.
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Scope Change Management
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Managing changes to the project is crucial to maintaining the integrity of both the Scope of Work and the Project Budget
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To control project scope
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Avoid “Scope Creep”, track scope changes, avoid gold plating
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Scope Creep
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gradual increase in project scope that can result from doing minor “additional tasks”
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Track Scope Changes
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Request change orders as required
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Avoid God Plating
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Do not provide more than what is defined in the scope of work or contract
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Contract/Procurement Management
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The processes required to acquire goods and services form outside your organization (contracts) -Procurement may involve outsourcing one project activity or an entire project
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Seller
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manages the project (contractor, vendor, supplier, ect)
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Buyer
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sponsor who provides funding for the project
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Procurement Management Procedures
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Plan purchases- perform “make or buy” analysis (in house or oursource) Plan Contracting-create procurement documents (Request for Proposal [RFP]) Reqest Seller responses (collect proposals) Select Sellers Contract Administration (ensure seller perfomance) Contract Closure
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RFP contains
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Scope of Work of the project, background info, instructions, information
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Contract
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Mutually binding agreement that obligates the seller to provide the specified product or service and obligates a buyer to pay for it
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Types of Contracts
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Fixed price, time and materials, unit price
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Fixed Price
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A fixed price for a well-defined project (most risk is with the seller)
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Time and Material
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cost of labor and materials to complete the project (“fee for service” (most risk is with the buyer)
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Unit price
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Pre-defined fee for completing a specific task
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Team operating rules
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problem solving decision making resolving conflict building consensus brainstorming conducting team meetings reporting project status
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Four stages of a successful project team
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1. Forming (directive) 2. Storming (Influence or Selling) 3. Norming (participative and decision sharing) 4. Performing (delegative)
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Team Decision Making Models
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Directive, Participative, Consultative
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Directive
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Person with authority (PM) makes all of the decisions. Some team members may not agree with the decisions and thus not support them
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Participative
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Everyone on the Team contributes to the decision-making process. (Usually results in synergy and strong support for team decisions, but often is very slow)
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Consultative
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The person with the authority makes decisions after consulting with Team Members (Can be as effective as “participative” and often takes less time)
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LISTENING
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Learn to “Like to Listen” Ignore distractions Summarize what you heard Tame your emotions Eliminate hasty decisions Never interrupt the speaker Inspire openness by your attitude Never finish the speakers sentences Generate your conclusions slowly
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factors that contribute to interpersonal communication
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words, vocal qualities, appearance and body language
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Enemies of Virtual Teams
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geography, isolations, history, culture,
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How to combat enemies of virtual teams
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geography-hold face to face kickoff meeting, teleconference Isolation-communicate History-project specific training Culture-honor cultural differences
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Email
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Most commonly used-abused project communication mode
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Effective email communication
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subject line (state core message) body (1st restate core message with more detail, make the top line your bottom line) 2nd-list required actions 3rd-add background info last-say something nice
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Managing Human Resources
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the activities required to make most effective use of the people involved with the project.
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Matrix organization
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-formed by overlaying a project structure on top of a functional structure
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Weak matrix
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PM may be part-time and has little authority. All project staff are borrowed
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Strong Matrix
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PM manage projects full-time, have administrative staff, exercise considerable authority over thier projects and are well respected within organization.
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Matrix organization strengths
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-provides balance between projects and business as usual -allows rapid adaption and innovation to meet changing company needs -supports flexible, efficient use of human resources -Provides good opportunities for staff professional development and building expertise in more than one project/product Pros: Efficient use of resources, less duplication of expertise. Allows balance between technical expertise & operational knowledge. Some Team members enjoy working on several different projects. Offers flexibility to the organization.
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Matrix organization weaknesses
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-team members have two or more bosses -can create conflict between functional and project managers -PMs often feel they have inadequate authority and ocntrol -Requires especially effective communication and can lead to conflict and stress within the project team Cons: Team members have two or more bosses, (confused loyalties). PM may not have enough authority to operate effectively. Line Managers may feel threatened. Complex reporting structure, can lead to conflict within the teams.
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Project Resourcing
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1. Identify the people 2. Obtain the people 3. Develop the people 4. Manage the people
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Team Organization Chart
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Defines formal and informal reporting relationships among people on the project Helps to identify communication and information channels
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Theory X
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Workers are inherently self-centered, lazy and lack ambition. Management must provide the drive for work to be accomplished (autocratic)
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Theory Y
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Workers are willing and eager to accept responsibility and are concerned with self-growth and achievement. management’s primary task is to provide an environment where workers can achieve and excel. (democratic)
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Expectancy Theory
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Workers will be highly productive and motivated if: they believe efforts will lead to successful results -they believe that they will be rewarded for their success
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Hertzberg’s theory of motivation
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motivators-recognition, advancement and growth, responsibility, the work itself demotivators-company policies, admin practices, working conditions, technical supervision, interpersonal relations, job security, salary
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Project Communications Management
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provides the critical link between stake holders and project info necessary for project success
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Five types of project communications
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formal written, informal written, formal oral, informal oral, electronic
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Formal written
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contract, communication plan, reports, plannin emails, cover letters
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Informal written
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project notes, memos, ect
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formal oral
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presentations, project reviews,
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informal oral
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team meetings, conversations
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electronic
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email, project websites, team rooms, ect
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Project Communication Channels
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if team size grows at a line
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Number of channels (N2-N)/2
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