Introduction to Project Management for Researchers


Published on

This presentation was given at the MRC during a workshop for applicants to the the DPFS/DCS scheme.

Published in: Health & Medicine
  • Be the first to comment

  • Be the first to like this

No Downloads
Total views
On SlideShare
From Embeds
Number of Embeds
Embeds 0
No embeds

No notes for slide

Introduction to Project Management for Researchers

  1. 1. Project Planning and Management Roger Tatoud, Ph.D. Senior Programme Manager International HIV Clinical Trials Research Management Office Imperial College London DPFS/DCS Workshop: 15 February 2013
  2. 2. Introduction • Background • From Bench to Bedside • Project Management • Why Project Management • Management Structure • Planning • Gantt Chart • Setting Milestones • Risk Management • Project Monitoring • Budget and MRC T&C • Your Project Manager 1
  3. 3. Background 2
  4. 4. Translational Medicine as a Linear Path Basic research Prototype Discovery & Design Pre-clinical Develop- ment Early clinical trials (I/II) Late clinical trials (III/IV) Regulatory approval Marketing Post marketing compliance Patient DPFS/DCS 3
  5. 5. Translational Medicine as a Mosaic 4
  6. 6. Systemic overview 5
  7. 7. What to do? Where to Start? 6 ... Project Management is here to help!
  8. 8. • Poor definition of objectives • Inadequate resources • Poor team and capacity issues • Poor communication • Lack of a cross functional team • Resistance to change • Lack of top management commitment • Poor leadership • Poor baseline management • Poor planning and control • Technical problems not resolved • Failure to anticipate problems • Too many uncontrolled changes • Lack of customer/user involvement Why Projects Fail? Adapted from HANDBOOK OF PROJECT MANAGEMENT © Trevor L Young January 2003 7 Leadership Team Work Management
  9. 9. • Assumed competency • Specification (scope) not specific • What are we doing? • Who does what and when? • Lack of individual commitment • Resistance to change • “I’ll do it my way” (great song, poor management) • The feeling that planning is an unnatural act • “I don’t work like that” • Over-optimism supported by our keen ability to underestimate everything • Bérézina Complex: “We will cross that bridge when we reach it” Why Projects Fail? Being Human 8
  10. 10. 1. Control scope and manage change 2. Deliver project results on time and on budget 3. Focus the project team on the solution 4. Obtain project buy-in from disparate groups 5. Define the critical path to optimally complete your project 6. Provide a process for estimating project resources, time, and costs 7. Communicate project progress, risks, and changes 8. Surface and explore project assumptions 9. Prepare for unexpected project issues 10. Document, transfer, and apply lessons learned from your projects Source: Why Project management? 9
  11. 11. 3D Approach to Project Management Manage Processes 10
  12. 12. Essential elements of Project Management • Good management • Effective record keeping • Good filing practices • Budget management • Good communication • On progress (looking backward) • On planning (looking forward) • Good project planning • Identify critical path & rate limiting activities • Enable allocation of sufficient time and resources • Good scenario planning / Risk management • Go/NoGo decision points • Be one step ahead of the game 11
  14. 14. 13 SC eGroup PMG TMG • Don’t recycle old management structures • Identify the needs of the project… • Bring together people that can contribute to issues arising in the project through… • Groups that will meet and communicate regularly. The Project Management Structure Research Stats Regulator Finance Clinical Database Admin Comm. IP Research Regulator Clinical Database IP Industry Industry Contract Contract Finance Stats Strategy Comm. Admin Strategy Operation
  15. 15. The Project Management Group Principal Investigator Strategic focus Project Manager Operational focus Project Management Group Experienced team members responsible for other roles PM+PI (PMG) Industry Regulators Clinical Researchers Funder University 14
  16. 16. Choosing a Project Manager • Appointed and involved at an early stage • Central point of contact for Project Team and Stakeholders • Empowered to do his/her job • Good organisation skills • Good communicator • Flexible, creative, resilient • Multitasker • Show initiative – know what (s)he knows and doesn’t • Think globally, act locally 15
  17. 17. Project Planning • First you need a plan! • A good project plan should monitor: • Timelines • Milestones • Budget • Resources Progress • Identify critical path / rate limiting activities • Enable allocation of sufficient time and resources • Project plans are dynamic - evolve as project develops • Level of detail will depend on target audience • The Gantt Chart... 16
  18. 18. • A graphical method of showing a project schedule that shows project time, dates of all activities and their relationships • For planning • For identifying dependencies • For identifying a Critical Path • For determining Milestones • For monitoring The Gantt Chart 17
  19. 19. 18 Gantt Chart - Planning of a Phase I trial
  20. 20. From Idea to Phase I - Manufacturing 19
  21. 21. Milestones - be SMART • Specific: objectives should be specific and written in clear, concise, and understandable terms. • Measurable: measurable outcomes allow determination of delivery. Set realistic and justifiable success criteria: Target value range and acceptable (cut-off) values. • Achievable: objectives must be aggressive but realistic – don’t be too ambitious! • Relevant: tasks and deliverables must focus on progressing the project along an appropriate (critical) development path. • Timely (deadlines not durations): objectives should have a realistic timeframe with an end date assigned to them. 20
  22. 22. Be SMART Objectives (ex: Detection of virus sequences in blood using new qPCR plateform) • 1. qPCR primer sets capable of amplifying 15 of 16 diverse blood samples tested with a combination of the assays targeting 3 virus genes using the fluorescent detection system • 2. The positive assays will yield a Ct of <10 and the negative control a Ct >38 • 3. The clinical isolates tested will yield Ct below background (sensitivity) and the correct positive call (specificity) on the Q-PCR platform 21 Success Criteria 1. qPCR primer sets amplifies 15 of 16 diverse blood samples tested with a combination of the assays targeting 3 virus genes using the fluorescent detection system. 2. The positive assays yields a Ct <10 and the negative control a Ct >38 3. The clinical isolates tested yields a Ct below background and the correct positive call on the Q-PCR platform
  23. 23. 22 • Example: development of an ultra low viral load assay • What? • How? • Results? • Variance • Go/No Go • What’s next? Identifying and writing milestones M Start Date End Date Month What is measured? How is it measured? What are the possible results? (Go/No go) Acceptable variance What happens then? Worded Milestone 1 01/10/12 31/03/13 6 Sensitivity of UL VL assay Lab assays <0.2 RNA copy/mL 10% Proceed to Stage 2 An UL VL assay with a sensitivity below 0.2 RNA copy/mL has been developed by Milestone End date>0.2 RNA copy/mL Contract Assay to Company X.
  24. 24. Risk and its management Project Schedule Issues RISKS Contains inherent… Which if they Occur become… Which if unresolved impact on… • Identify & evaluate risks • Identify risk ownership • Mitigation • Prepare a response & contingency plans • Continuous process • Identify early & resolve promptly • Constraints # Risks 23
  25. 25. • Strategic risks concern long-term strategic objectives of the project. This type of project risks affects such areas as initial project financing, technology, reputation, changes in the physical environment, etc. • Operational risks concern issues and problems that project participants are confronted with from day to day. Mitigation of operational risks contributes to reducing of strategic risks. • Compliance risks concern issues associated with the need to comply the project course with documented statements and regulations. Managing compliance risks lets ensure that current project activities are undertaken in the manner which project stakeholders and customers expect. • Financial risks are associated with existing financial structure of the project and with all the transactions made to carry out the project. Identification of financial risks involves examining daily operations. Financial risks are an indicator that shows whether current project has serious implications for viability. • Knowledge risks are associated with effective management and control of knowledge resources, communication mechanisms, and protection systems. Project knowledge risks may include abuse of intellectual property, loss of the key project staff, system malfunction, etc. Type of risk and their estimation 24
  26. 26. Quantifying risk – Assessing impact • Probability of occurrence • Impact on the project • Decided by team consensus • Identified at the start • Added as required • Reviewed regularly Impact on the project (conservative matrix) Low Medium High Probability 0.65 - 1.00 Medium High Not acceptable 0.30 – 0.64 Low High Not acceptable 0.0 – 0.29 Low Medium High • HIGH: Major Impact, serious consequences. Likely to affect a Milestone, must be monitored regularly and closely • MEDIUM: Significant impact, not expected to affect a Milestone, monitor regularly • LOW: Not expected to have a serious impact. Review regularly for ranking 25
  27. 27. • Progress • Risks • Finance • Monthly PMG meeting (TMG, SC, eGroup) • Ad hoc meetings (milestones, finance) • Quarterly Reports • Milestones Reports • End of grant report • Publications • Capacity building • Commercialisation Project Monitoring & Evaluation 26
  28. 28. Good Meeting Management practice • Schedule regular meetings – with reminders (use Outlook!) • Request status report (provide template!) • Circulate agenda in advance – seek input from team members • Circulate status report and relevant papers (early enough) • Chair meeting – keep to time (park what needs to be parked) • Start by reviewing previous Action Points– close completed APs • Identify issues requiring a decision by whom and when • Identify Action Points, their owner(s) and a due date • Circulate minutes/actions for comment within 2-3 days • Sooner if some actions require immediate action • Finalise sign-off minutes at next meeting • Follow up 10 days later 27
  29. 29. • When setting budgets consider cost beyond basic research and clinics • Travel, publications, samples shipment • Regulatory support (consultants) • Regulatory meetings in response to data • Storage cost IMP (GMP) • Storage cost samples (short and long term) • Labelling, packaging, shipping • Pharmacy (equipment), set up fees (clinical site) • Ensure grant is set up in your system and that your finance and admin people know about it Budget and resources 28
  30. 30. Conclusion • Diversity • Complexity • Relationships • Dependencies • Stakeholders  Managing a Project… …is managing change 29
  31. 31. • Trevor L. Young Young is an expert project management practitioner and his book provides everything needed to manage a project from start to finish in a clear, concise and to the point style. Many of the templates I use are based on his work. • The Handbook of Project Management: A Practical Guide to Effective Policies, Techniques and Processes • Scott Berkun Berkun’s books are an everyday reminder that tools are as good as those who use them and that however good they may be, they are no magic bullet for successful project management. Berkun also debunk a number of myths about project management and challenges many management clichés (such as “thinking outside of the box”). • Julie Warneck Protogenia Consulting Ltd • Loic Lhuillier Translational Research Portfolio Manager King’s College London/NIHR BRC 30 Acknowledgement