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PROJECT MANAGEMENT

PROJECT MANAGEMENT. WHAT WE WILL LEARN TODAY. PROJECT PROJECT MANAGEMENT PROJECT TEAM PROJECT PLANNING GANTT CHART CPM PERT. PROJECT. A series of related activities or tasks usually directed toward some major output and requiring a significant period of time to perform

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PROJECT MANAGEMENT

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  1. PROJECT MANAGEMENT

  2. WHAT WE WILL LEARN TODAY • PROJECT • PROJECT MANAGEMENT • PROJECT TEAM • PROJECT PLANNING • GANTT CHART • CPM • PERT

  3. PROJECT • A series of related activities or tasks usually directed toward some major output and requiring a significant period of time to perform • A temporary venture undertaken to create a unique product e.g. drug or service (clinical trial) • Temporary- a distinct start and a distinct end. • Factory/ software/ drug • Duration – time from beginning to completion

  4. PROJECT MANAGEMENT • PLANNING, SUPERVISING, AND MANAGING RESOURCES (manpower, money, machines, materials) to meet the technical, cost, time and quality requirements of the project. • A process to quantify the resources – amount of time and money- a project will cost • GOAL- to control key variables- time, quality and cost • Planning, implementation and monitoring requires a project team

  5. PROJECT TEAM • A CT project team • Project Manager • Medical Adviser • Clinical Research Associates • Data Manager • Statistician • Regulatory Affair Manager • Trial supply pharmacist

  6. PROJECT MANAGER • Overall responsibility for the successful planning and execution of project. • Life science background – 5 yrs experience in pharma or CRO • Thorough understanding of planning proces and appreciation of critical elements in integrated trial management function (local and global) • Able to consider strategic, tactical and operational issues and options and practical management of project by critical path analysis

  7. RESPONSIBILITIES OF “Project Manager” • leading the project team • Developing project budget • Coordinating and tracking project activities • Creating and controlling project timelines • Directing team meetings • Managing project resources • Preparing agendas and minutes of meetings • Handling project communications

  8. REQUIREMENT OF TRAINING • Needs training in • Drug development • Leadership • People management • Cost and budget management • Time management • Problem solving • Communication • Effective presentation • Negotiation

  9. MANAGING THE PROJECT • STAGES • Project initiation • Project planning • Project execution • Project monitoring • Project completion

  10. PROJECT INITIATION • Two major activities • Development of project proposal • Deciding the objectives of project • Written description of objectives • Brief statement of work to be done • Proposed schedule specifying start and completion steps • Description of budget • Measures of performance • Project milestones • Work breakdown structure • Number of levels - tasks/ subtasks/ work package

  11. PROJECT PLANNING • Develop a plan to track the progress of tasks • DETERMINE EXACT END POINTS - for success of project – number of patients to be completed in expected time frame • DESCRIBE ALL KEY TASKS - to be done by each team member – how much time it will take to complete each activity • REQUIRED SEQUENCE OF ACTIVITIES- how each task depends upon each other - identify immediate predecessor- sequence the tasks into likely completion order and create a project network

  12. REGULATORY PERMISSION- subdivided into subtasks • Preparation of protocol, case record form and consent documents • Obtaining conent and undertaking from investigator • Compilation of IND application • Submission of IND application

  13. DETREMINE CRITICAL PATH- • Assess minimum time project will require • Longest path through network from start to finish – critical path (any delay will delay the overall project) • If single estimate of time is not reliable, then create three estimates

  14. IDENTIFY RESOURCE REQUIREMENT- • Manpower, money, machines and materials for each task • Time cost model- link between time to complete the task and money required- develop minimum cost schedule for entire project and control expenditure during project • It costs to expedite activity • It costs to sustain or lengthen project

  15. DEVELOP PROJECT SCHEDULE- • Project control charts • Milestones • project start date • Document completion dates • approval dates • Site initiation • First patient first visit • Recruitment of 50% of subjects • Last patient first visit • Last patient last visit • Database lock • report

  16. ANTICIPATE PROBLEMS – plan for risk management • DISCUSS PLAN with team members and obtain their commitment

  17. PROJECT CONTROL CHARTS • GANTT CHART – a bar chart showing both time and sequence, in which activities are performed • Relate activity to time in usable fashion • For small projects - unsuitable for large and complex project (>25 activities) – difficult to visualise interrelationship of activities • Does not provide direct procedure for Critical Path

  18. CRITICAL PATH METHOD • A type of Network Analysis • More complex than Gantt Chart • Illustrates and documents how processes are interdependent • Based on assumption that project activities times can be accurately estimated • OBJECTIVE – to determine scheduling information about each activity in project • Critical path of activities is the sequence of activities that form the longest chain in terms of time to complete

  19. CRITICAL PATH ACTIVITIES FOR A CT PROJECT • Prepare protocol, CRF, IB, consent • Select investigator and obtain undertaking • Apply for clinical trial + import/ export permission • Obtain clinical trial + import/ export permission • Obtain trial supplies • Distribute trial supplies to site • Initiate sites • Enroll first patient • Complete last patient last visit • Complete monitoring visits • Lock data base • Analyse data base statistically • Prepare report

  20. NETWORK ANALYSIS- PERT/CPM

  21. NETWORK ANALYSIS- PERT/CPM 1 2 3 D 1 ACTIVITY BEGINS B 5 ACTIVITY ENDS F 1 A 2 5 6 2 1 E 6 C 1 4

  22. PERT/ CPM

  23. PROJECT EXECUTION • Running the report as per plan • Reporting the achievement milestones • Reviewing &modifying project plan if needed • Project is tracked by tracking Gantt Chart / CPM- superimpose current schedule on planned schedule to get any deviations

  24. PROJECT CONTROLLING • A key responsibility of project manager • Monitor in terms of time, money and other resources and plan risk management • RISK - a possible event, which can negatively affect the schedule cost of quality • Actions in risk • Changing the project timelines • Adding more resources • Terminating the project in the eventuality

  25. PROJECT CLOSEOUT • Conclusion of project • Achievements vis-à-vis objectives • Time taken vs. Time schedule • Cost incurred vs. budget • Problems faced and solved

  26. GUIDELINES FOR MAKING PPT • GUIDELINES • No more than 8 lines in one slide. • Use minimal & simple animation techniques and a standard ppt design by all candidates. • Use coloured text for better enhancing your point. Identify your heading by making it bold or in colours. • Don’t use full sentences on the slide, instead keep a printed form for your reading.

  27. Don’t read from slide except “DEFINITIONS” • Standard size of letters – • HEADING – SIZE 40-44 (THIS CAN BE COLOURED) ; • MAIN TEXT – 28-32 (USE SIMPLE ANIMATION TO BRING IN YOUR POINTS ON THE SLIDE. • ANY OTHER SUGGESTIONS

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