Jobs / Japan / Glaxosmithkline LLC
Site Engagement Lead
Glaxosmithkline LLC · 🌍 Japan - Tokyo - Akasaka
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About the role
Job Purpose Through his/her leadership, the Site Engagement Leader is accountable for developing, managing and overseeing long-term and strong relationships with strategically and operationally important sites and institutions. It includes building and enhancing the image and reputation of GSK with sites locally and providing an interface between GSK and the sites to create an optimal clinical trials environment to generate results in a timely manner with high-quality outputs. Key Responsibilities • Develop a site engagement plan, and lead the development and expansion of institutions / sites building and nurturing relationships across site types, including academic centers, community practices and emerging site models that support delivery of the GSK R&D portfolio; develop the GSK portfolio of clinical investigator sites through partnerships to attract more studies in the country, ensuring development, co-ordination and oversight of partnership activities conducted with institutions / sites where high potential of patient recruitment, quality of data and technical support exist. • Drive collaboration with Japan Development, Japan Medical Affairs, and leadership teams (including the central site engagement and the Local Operating Company (LOC)) regarding the development of partnerships and updates to existing ones; Build and maintain strong, trusted relationships with investigators, research coordinators, and site leadership. • Give an operational vision of the future GSK clinical research therapeutic areas and GSK portfolio to key external stakeholders to anticipate partnerships and to help research institutions and sites better prepare the arrival of clinical trials. • Provide strategic input for operational excellence, process efficiency and trial delivery both internally and externally; identify and share best practices at internal cross functional process improvement teams, contributing to efficient and consistent ways of working to optimizing quality and productivity across LOC / region / global site network as appropriate. • Drive performance, by putting in place mutually agreed KPI targets (quality and performance) and organizing regular, periodic performance reviews with the different external partners track compliance with mutually agreed action plans, implementing targeted solutions to reduce cycle times across the study lifecycle and optimize enrolment; participate in/lead site visits to deliver targeted operational support and address site-specific challenges. • Work closely with sites and with members of the LOC Clinical Operations Department to proactively identify bottlenecks at both the study and site level and any risks to quality and compliance and to develop and implement mitigation plans to address these risks, supporting corrective actions to ensure successful outcomes • Collaborate with planning and Feasibility teams, Clinical Operations and Medical Affairs to drive optimal site placement and study performance; can lead / contribute to high level country feasibilities for new TAs and support the local teams with feasibilities and partner with cross functional teams to optimize site activation timelines (regulatory packets, budgets/CTAs, onboarding, training) as appropriate. ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification • Bachelor’s degree in related discipline, preferably in life science, or equivalent experience • Minimum 5 years’ experience in clinical research operations or similar positions in the pharmaceutical industry • Therapeutic area experience in Oncology, Respiratory or Hepatology • Solid knowledge of ICH-GCP, local regulations and regulatory processes, and excellent understanding of the Clinical Operation Process, including monitoring • Demonstrated leadership skills