PROJECT PROJECT MANAGEMENT PROJECT TEAM PROJECT PLANNING GANTT CHART CPM PERT

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

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

A CT project team Project Manager Medical Adviser Clinical Research Associates Data Manager Statistician Regulatory Affair Manager Trial supply pharmacist

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

◦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

Needs training in ◦ Drug development◦ Leadership◦ People management◦ Cost and budget management◦ Time management ◦ Problem solving◦ Communication◦ Effective presentation◦ Negotiation

STAGES◦Project initiation◦Project planning◦Project execution◦Project monitoring◦Project completion

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

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

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

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

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

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

ANTICIPATE PROBLEMS – plan for risk management

DISCUSS PLAN with team members and obtain their commitment

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

s.no.

TASK START END

1. Prepare protoco, IB, CRF, consent

01 May 2010 30May 2010

2. Obtain regulatory document

01 Jun 2010 30 Jun 2010

3. Modify & translate consent 01 Jun 08 Jun

4. Select investigator & obtain undertaking

30 Jun 30 Jul

5. apply for clinical trials + import/export permission

01 Jul 07 Jul

6. Apply for ethics committee approval

01 Jul 07 Jul

7. Hold investigator meeting 01 Aug 07 Aug

s.no.

TASK START END

8. Obtain clinical trial+ import export permissio9

9. Obtain ethics committee approval

10. Import trial supplies

11. Distribute trial supplies to sites

12. Initiate sites

13. Enroll first patient

14. Prepare CRF for data entry

s.no.

TASK START END

15. Design data base

16. Start monitoring visits

17. Start data entry

18. Complete last patient last visit

19. Complete monitoring visit

20. Lock data base

21

22.

Analyse data statistically

Prepare report

s.no.

TASK Q1.2010

Q2,2010, Q3,2010 Q4,2010

1. Prepare protoco, IB, CRF, consent

2. Obtain regulatory document

3. Modify & translate consent

4. Select investigator & obtain undertaking

5. apply for clinical trials + import/export permission

6. Apply for ethics committee approval

7. Hold investigator meeting

s.no.

TASK Q2,2010

Q3,2010 Q4,2010 Q1.2011

8. Obtain clinical trial+ import export permissio9

9. Obtain ethics committee approval

10. Import trial supplies

11. Distribute trial supplies to sites

12. Initiate sites

13. Enroll first patient

14. Prepare CRF for data entry

s.no.

TASK Q1,2011 Q2,2011 Q3,2011

Q4,2011

15. Design data base

16. Start monitoring visits

17. Start data entry

18. Complete last patient last visit

19. Complete monitoring visit

20. Lock data base

21

22.

Analyse data statistically

Prepare report

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

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

ACTIVITY DESCRIPTION

Duration Immediate precedence

A Obtain budget approval

2 -

B Obtain machine

5 A

C Hire operator

1 A

D Install machine

1 B

E Train operator

6 C

F Produce goods

1 D,E

1 2

ACTIVITY BEGINSACTIVITY ENDS

1 2

4

3

5 6A 2

B 5

C 1

D 1

E 6

F 1

S.No. PERT CPM

1. Probabilistic in nature Deterministic, known certainty

2. For projects that are new, non repetitive, research

For repetitive, standardised, construction

3. Primary focus n time element, lesser significance to cost

Strong focus on cost, cost time relation

4. Variation in time is inherent Systematically varied

5. Event oriented Activity oriented

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

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

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

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.

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