This is a set of slides to provide basic overview of the Site Start-Up Team lead role and responsibilities and what are the expectation of this role.

1. Site Start-Up Team Lead General Training Presentation By Navdeep Mahajan 1

2. Site Start Up 2 Identification of Sites IP Release Site Contract Negotiation Regulatory & Ethics Submissions A D C B Contract Negotiation and Execution of all Site Contracts IP Release Site ID Ethics and/or Regulatory Submissions and Translations SSU Timeline: Post Award Site ID –> IP Release

4. Monitors regional status information and identifies the need for adjustments

5. Develops and agrees up-front solutions, contingency plans.

7. WHO IS AN SSU LEAD 5

8. Responsibilities Primary Contact for global CTL, PM and RTL. Develop Start-Up Project Plan Ensure Uniform Standards are applied Design Project Instructions – SSU Activities Assess Project Risks and develop contingency plan (For Start-up Part ONLY) 6

9. Responsibilities Present Updates on a weekly meeting to Global Team and/or Sponsor Manage Weekly meeting with Local SSU teams for updates and project progress/planning Encourage and Support Issue Escalation Track Study progress using various tools like CI, and weekly meetings 7

10. Responsibilities Track Team Performance and highlight performance issues at the right time to LMs Responsible for Project Specific Training, Mentoring and supervising the Local SSU teams Accountable for ALL SSU Deliverable and Timelines Conduct “Lessons Learned” after SSU Closeout 8

11. WORK FLOW 9

13. Complete the Start Up Checklists items with CTL and/or PM

14. Discuss Scope of Activities, SOPs, Contracts, etc.

15. Discuss Milestones, Study Deliverables

16. Brief protocol overview, etc. SSU lead will be required to make a presentation on SSU activities, resources and expertise during these meetings. 10

17. The Work Flow 2. Project Planning Set up goals for self and the team. Arrange for weekly team meetings. Arrange for methods on receiving and providing study updates. Arrange for Site Identification. Plan Ethics Committee/Regulatory Authority Submissions. Plan for Contracts and Investigator Budget. Project Instructions for Investigational Product release documents (Essential Documents) and any other SSU activities where required. 11

18. The Work Flow 3. Project Execution Ensure weekly meetings are conducted throughout the start up phase and get updates from local SSU team Ensure to attend weekly Sponsor/Global Team Calls and provide most recent updates. Ensure all activities are proceeding as per plan and any delays seen must be addressed immediately Track all project delays from Sponsor or global team closely, as these would affect the team and individual metrics. 12

19. The Work Flow 3. Project Execution (Cont.) Ensure all critical documents (ex: EC Approvals, RA Approvals, Export Licenses, etc.) are reviewed as and when they have been received to avoid surprises towards the time of IP release. Manage ICF finalizations and Translations. Manage Staff Transitions if any during this period. Primarily responsible for Contract negotiation with sites that have been not managed by SSU staff. 13

20. The Work Flow 3. Project Execution (Cont.) QC for the IP release documents (may need to sign as reviewer/approver depending on agreement with CTL/PM). Ensure all activities being undertaken are as per the scope agreed and any out of scope activities must be captured in and shared with the PM towards the end of Start up activities or as and when a change order is due. 14

21. The Work Flow 4. Project Close-Out (All SIVs Complete) Ensure all Contracts have been executed and copies of these have been Filed. Ensure all Site Handovers have been completed and sent to CRA/CTL. Ensure you have received confirmation from PM/CTL on wrap up of SSU activities Track your metrics “Lessons Learned” Session for entire team 15

22. CHALLENGES 16

23. Challenges Understanding each country Regulatory Requirements and the environment Understanding Cultural Difference in handling teams Understanding that SSU is still in it’s INFANCY in many companies and in the region and hence processes are not yet streamlined Usually regional roles require a lot of multi-tasking and appropriate delegation Timely follow up due to different holiday periods Constant mentoring and eliciting high performance 17

24. LESSONS 18

25. Lessons Always and Always Set Realistic Timelines in consultation with Local SSU teams and their LMs Never over commit even if it appears to be possible by Stretching Manage Performance right from the start of the study and escalate any non performing resource/ team to line managers Have a weekly call with the full SSU team or by country to get updates other than via emails and CI. Keep the communication channel transparent Identify your back up while you are on planned leave well in advance 19

26. Lessons Highlight Potential Delays in Start up right at the KO meeting. Track all out of scope activities Ensure adequate and proper training is provided to the local SSU teams. Involve in Contract Negotiations where required and not for every site. Review of Critical documents real time. 20

27. Some DON’Ts SSU Lead is not part of the Investigator Budget finalization. We only negotiate the provided Budget! SSU Lead will not take onus for responding to EC queries related to the Protocol. We will only facilitate the queries between site – sponsor! SSU Lead will not assist in Investigator Meeting related activities nor the CRA training! SSU Lead will not be part of detailed Protocol training! SSU lead will not review the Master ICF with respect to the protocol and will review it only for GCP and Local requirements! 21

28. Some DON’Ts SSU Lead will not involve in justification for export and Import Licenses SSU Lead will only assist in RA Submissions unless no CTL is identified at that time. SSU Lead will not be responsible for queries from sites after SSV related to protocol. 22

29. Thank You and any……. 23