.**Description****JOB TITLE: Site Start-Up Project Delivery Lead****SELECT ONE: Clinical Solutions****JOB CODE**:SH2313****JOB FAMILY**:**BUSINESS UNIT****(COMMERCIAL ONLY)**:**REPORTS TO**: Associate Director, Site Start-Up & Regulatory or designee****JOB SUMMARY**:Responsible and accountable for the customer-focused leadership and management of Site Start-Up (SSU) deliverables within a region or globally, within the assigned projects or programs. Directs the technical and operational aspects of the Site Start-Up deliverables of the assigned projects. Accountable for the delivery of activation-ready study sites on time, on budget, and in compliance with all applicable regulations. Responsible for overseeing all Site Start-Up activities from site selection/recommendation through site-activation ready. Develops integrated SSU timelines and reports weekly progress including plans to address potential risks/gaps to the project team, Project Manager (PM), SSU Management and Project Sponsor.**JOB RESPONSIBILTIES**:- Collaborates with major functional area leads (SSU Country Managers, Project Management, Clinical Management,) to identify and evaluate fundamental issues pertaining to Site Start-Up, project regulatory pathway, successful patient enrollment, interpret data on complex issues, make good business decisions, and ensure solutions are implemented. Ensures all project deliverables meet the internal and customers' expectations as per contracted deliverables, providing accurate projections, reports and updates, and ongoing risk assessments.- Develops and maintains relationships with customers in alignment with their assigned projects. May collaborate with business leads for business development, alliance management, contracts and proposals development, project management, and clinical management to achieve project goals. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed. Contributes to change initiatives across and within the SSU department.- Provides oversight of all project SSU deliverables which encompasses all activities from site selection through site activation ready.- Assumes accountability on SSU deliverables including, but not limited to:- Start-up regulatory activities (submissions, oversight of communication to competent authorities/ethics committees, import/export licenses, study maintenance submissions); - Oversight of delivery of executed clinical trial agreements and investigator budgets with investigator sites- Establishing Essential document collection leading to site activation; - Overall SSU timelines to site activation.- Develops plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables