Introduction to Project Management for Researchers

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

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

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  • 1. Project Planning and ManagementRoger Tatoud, Ph.D.Senior Programme ManagerInternational HIV Clinical Trials Research Management OfficeImperial College LondonDPFS/DCS Workshop: 15 February 2013
  • 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. Background 2
  • 4. Translational Medicine as a Linear Path Prototype Pre-clinical Post Basic Early clinical Late clinical Regulatory Discovery & Develop- Marketing marketing Patientresearch trials (I/II) trials (III/IV) approval Design ment compliance DPFS/DCS 3
  • 5. Translational Medicine as a Mosaic 4
  • 6. Systemic overview 5
  • 7. What to do? Where to Start? ... Project Management is here to help! 6
  • 8. Why Projects Fail?Adapted from HANDBOOK OF PROJECT MANAGEMENT © Trevor L Young January 2003• Poor definition of objectives• Inadequate resources• Poor team and capacity issues• Poor communication Team Work• Lack of a cross functional team• Resistance to change• Lack of top management commitment• Poor leadership Leadership• Poor baseline management• Poor planning and control• Technical problems not resolved• Failure to anticipate problems Management• Too many uncontrolled changes• Lack of customer/user involvement 7
  • 9. Why Projects Fail? Being Human• 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” 8
  • 10. Why Project management?1. Control scope and manage change2. Deliver project results on time and on budget3. Focus the project team on the solution4. Obtain project buy-in from disparate groups5. Define the critical path to optimally complete your project6. Provide a process for estimating project resources, time, and costs7. Communicate project progress, risks, and changes8. Surface and explore project assumptions9. Prepare for unexpected project issues10. Document, transfer, and apply lessons learned from your projects Source: 9
  • 11. 3D Approach to Project Management Manage Processes 10
  • 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. The Project Management Structure • 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. SC Strategy Research PMG Clinical Operation Admin FinanceContract Finance Comm. Admin Contract IP IP Database Strategy Stats TMG eGroup Clinical Regulator Comm. Stats Industry Research Regulator Industry Database 13
  • 15. The Project Management Group Principal Investigator Industry Strategic focusUniversity Regulators Project Manager Operational focus PM+PI (PMG) Project Management Group Experienced team members Funder Clinical responsible for other roles Researchers 14
  • 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. 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. The Gantt Chart• 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 17
  • 19. Gantt Chart - Planning of a Phase I trial 18
  • 20. From Idea to Phase I - Manufacturing 19
  • 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. Be SMARTObjectives (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 platformSuccess Criteria1. qPCR primer sets amplifies 15 of 16 diverse blood samples tested with acombination of the assays targeting 3 virus genes using the fluorescent detectionsystem.2. The positive assays yields a Ct <10 and the negative control a Ct >383. The clinical isolates tested yields a Ct below background and the correct positivecall on the Q-PCR platform 21
  • 23. Identifying and writing milestones • Example: development of an ultra low viral load assay • What? • How? • Results? • Variance • Go/No Go • What’s next?M Start End Month What is How is it What are the Acceptable What happens Worded Milestone Date Date measured? measured? possible results? variance then? (Go/No go)1 01/10/12 31/03/13 6 Sensitivity of Lab assays <0.2 RNA copy/mL Proceed to Stage 2 UL VL assay An UL VL assay with a sensitivity 10% below 0.2 RNA copy/mL has been >0.2 RNA copy/mL Contract Assay to developed by Milestone End date Company X. 22
  • 24. Risk and its management • Identify & evaluate risks • Identify risk ownership • Mitigation Project Schedule • Prepare a response & Contains inherent… contingency plans • Continuous processWhich if unresolved impact on… RISKS • Identify early & resolve promptly Which if they Occur become… • Constraints # Risks Issues 23
  • 25. Type of risk and their estimation• 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. 24
  • 26. Quantifying risk – Assessing impact • Probability of occurrence Impact on the project (conservative matrix) • Impact on the project Low Medium High • Decided by team consensus 0.65 - 1.00 Medium High Not acceptable Probability • Identified at the start Not 0.30 – 0.64 Low High acceptable • Added as required Medium 0.0 – 0.29 Low High • Reviewed regularly• 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. Project Monitoring & Evaluation• 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 26
  • 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. Budget and resources• 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 28
  • 30. Conclusion• Diversity• Complexity• Relationships• Dependencies• Stakeholders Managing a Project… …is managing change 29
  • 31. Acknowledgement• 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