Local Feasibility Lead

• LFL is accountable for ensuring local stakeholders (MSL, other MA, other SM&M) receive invite for global KOM (KEE outreach / site feasibility) and have access to the meeting pre-reads.
• Following global KOMs, with local stakeholder input, the LFL agrees the strategy for local outreach. The LFL sets clear expectations for the local team to meet the timelines and objectives set by global feasibility. To include a decision as to how sites will be approached for site feasibility through drugdev, direct call as deemed appropriate by local team and per PiC network guidance.
• LFL is accountable for confidentiality arrangements in place with sites prior to any outreach.
• LFL proactively uses all local team site intelligence and external sources to facilitate site identification for KEE / site feasibility outreach.
• When using drugdev, LFL maintains oversights of site feasibility responses to ensure proactive follow up with non-responders as needed to achieve a high level of site responses contributing to a robust country response.

Summary

Global Level

• Represents Country at LFL Forum, sharing best practice and optimisations
• Main point of contact with Global Feasibility and Portfolio Delivery Teams

Country Level

• Seeks feedback from DSMM on TA portfolio to initiate feasibility activities.
• Ensures local stakeholders are involved in all aspects of feasibility process –KOM, study design insights, site selection, analysis of feedback, SMM response.
• Coordinates completion of local feasibility activities to ensure SMM response, confirmed by country head is delivered on time.
• Ensures country team members involved in feasibility are trained as needed on current feasibility tools and methodology, and best practice
• Coordinates local handover to LST to ensure continuity from feasibility through start up.
• LFL is accountable for ensuring all relevant local stakeholders are involved in providing input to the SMM response and that the final SMM response is agreed with CH.
• LFL identifies risk to recruitment delivery and seeks inputs from local stakeholders to develop strategy for recruitment prior to study start up.
• LFL proactively completes heatmap throughout the feasibility process to identify risks and contingency strategies to identify solutions for local country which may also support discussions in other countries.
• As part of the handover process to the local start up team, the LFL is responsible for informing the LSAD of the country selection to complete the early planning in VCV, providing all feasibility information prior to commencing SQ, outputs from KEE engagement, heatmap insights, access to global study team training. LFL to provide input into the decision as to whether a partial / full SQ assessment is required.