Site Engagement Lead
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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 and experience working in matrix teams
Strong client relationship and stakeholder management abilities
Agility to adapt to evolving strategic, operational, and pipeline landscapes
Fluent level of Japanese and Business level of English (spoken and written)
※日本での就労資格を有すること。
Preferred Qualification
Demonstrated track record of establishing and growing partnerships with strategic sites / institutions
Solid knowledge of and enthusiasm for digital solutions and technology; experience helping others on their digital and technology growth journeys
Experience in designing, creating, and developing new and innovative ways of working (both across functions and externally)
Demonstrated knowledge of industry trends, with the ability to anticipate the evolution of clinical research and to propose strategic plans to optimize delivery
Strong analytical and synthesis skills, including data story-telling
Adaptability and a bias for action; anticipates and recognizes potential and present obstacles and proactively works to prevent, overcome and/or resolve them
Approaches change positively, helping self, team, and the business adapt. Views change as an opportunity to enhance performance and deliver added value.
Acquire and maintain therapeutic area and product knowledge across GSK portfolio
Skills
Agile Thinking, Business Acumen, Clinical Development, Clinical Research, Clinical Sciences, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, Pharmaceutical Industry, Project Management, Time Management
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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
This Position Description is to provide a framework for job understanding between employee and manager. It may not cover or contain the full listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice and at the discretion of the management of the Company. The position description is not used in the assignment or assessment of any GSK level or grade used in the Job Evaluation Process.
Compensation Grade:
Japan - 7A
Job Posting End Date:
Not Available
Eligible for Employee Referral Bonus:
Yes
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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