-グローバル試験の立ち上げ進捗管理（Kick of Meeting~RGL取得までのプロセスを、専用社内システムを用いて管理）、現場からの質問対応、書類・費用のレビューなども実施
-業務上のカウンターパート：スポンサー、PM、Lead CRA、SSU Specialist、SSU Manager、GlobalPDLなど
・ 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.
・ Develops and manages integrated site start-up timelines and reports weekly progress including plans to address potential timing risks/gaps.
・ Prepares and presents overall SSU strategy and status at client meetings and communicates outcomes to project team.
・ Reviews the project SSU budget with the functional leads, PM, and the SSU Business Unit Controller against project milestones and budget to ensure project profitability. Takes corrective measures where necessary to keep projects in line with budget and gross profit expectations.
・ Uses professionally recognized tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested,notifies the PM and SSU Manager and tracks out-of-scope work until it is assigned to back log.
・ Prepares the core submission documents and core clinical trial application dossier.
・ Assists in development of master Patient Information Sheet (PIS) /Informed Consent Form (ICF) in collaboration with the PM and medical department.
・ Oversees collation, quality review, and submission of country-specific applications.
・ Accountable for the timely follow-up for Ethics Committee/Competent Authority enquiries or objections in collaboration with the country SSU Specialists. Meets or exceeds the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is
identified, solves or escalates the problem quickly.
・ Accountable for the oversight of negotiation and execution of clinical trial agreements and budgets in accordance with agreed timelines. Includes coordination of internal and external stakeholders in the development and/or provision of required clinical trial agreement templates and investigator site budgets, oversight of local contract negotiator colleagues and assistance in resolving negotiation barriers, and periodic progress reporting to the client and other stakeholder groups.
・ Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
・ Participates in new business development activities including participation at client presentations.Provides information to support business development activities.
■休日：完全週休二日制, GW, 祝日, 年末年始, 土, 日