Clinical Trial Educator

画像診断は客観的な臨床評価指標・バイオマーカーとして信頼性が高く、製薬メーカーが行う医薬品の臨床試験（治験）にも積極的に利用されつつあります。 画像解析事業部では、治験のエビデンスとして用いられることとなる医用画像にかかる一連の業務を行います。 【具体的には】 　・治験事前準備：撮像条件を統一する為、施設毎にファントム試験や調査を実施し、治験撮像手順書を作成。（施設毎に用意された手順書に則って治験時には撮像を行ってもらう） 　・画像ＱＣ：ワークステーションを使用して、規定された撮像条件が遵守されているか？一定の画質を維持できているか？の確認。 　・画像処理：ワークステーションを使用して、読影をスムーズに行うための画像処理。 　・画像解析：依頼者の要望に応えて、医用画像の新たな解析手法を提案・実施。 　・読影会（判定会）：判定医の先生に医用画像を用いて治療薬の効果を評価していただく会を運営。 【業務内容】 「応募資格」を満たす方は、特に以下の業務へも力を発揮していただくことを期待しております。 ・受託時に発生する画像解析方法の検討（コンサル～撮像方法、解析方法の検討） 【キャリアパス】 「薬効評価に医用画像を用いる」 上記のことを専門的に行っている企業は少なく、パイオニアとしての活躍が期待されます。 臨床開発の中のとりわけオンコロジー領域に特化したスペシャリストを目指していただけます。（医師や研究者との情報交換も多く、専門性を磨く機会は数多くあります） 【やりがい】 当社の画像解析事業部の受託は現状4～5割が抗がん剤の有効性評価に係るプロジェクトです。オンコロジー領域のご経験をお持ちであれば画像評価の専門医と一緒になって判定基準の設計や専門医へのトレーニング等に活かすことが出来ます。 先行他社がいない状況で、進む道を切り開いていく面白さがあります。

部門紹介 Centralized Monitoringチームは、主にRisk Based Monitoring （RBM)における中央モニタリングに関連するサービスを提供する部署です。クリニカルチームや顧客とのコミュニケーションを通じて、RBM適用プロジェクトをマネージする役割を担っています。また、データに基づくモニタリングを推進するため、CRAを支援するための社内サービスを提供しています。 仕事内容 ■職務概要 PythonやVBA、SASなどのプログラミング言語やBIツールを使用して、社員の業務効率化に係わるプログラムやツールを開発する業務 ■職務詳細 • BIツールを使用したグラフやリスティングの開発(仕様書作成やバリデーション含む) • データの集計プログラムの開発(仕様書作成やバリデーション含む) • 定型作業を自動化するプログラムの開発等

ACCOUNTABILITIES This position will report to the Head of Global CSR and is responsible for the project management of Global CSR Program and supporting the effective execution and tracking of day-to-day duties of its ongoing projects. Responsibilities include: Lead and manage Global CSR Program project planning, work plan development and monitoring, and reporting to ensure effective communications between program partners, the Global CSR team, and involved internal stakeholders. Coordinate routine reporting and monitoring of Global CSR Program partners, track progress and reporting on results (including outcome data), manage payment process and donation usage reviews, help identify and mitigate risks, and help resolve conflicts and issues. Ensure that a result framework for managing results is in place and regularly tracked for each new Global CSR Program project by closely working with Global CSR Program partners. This includes how the project contributes to sustainable impact, by defining outcome and output indicators and establishing baselines at onset and tracking progress towards targets. Contribute to further development of a result framework towards tracking and demonstrating by data the effectiveness and impact of our Global CSR Program Support the day-to-day management of Global CSR’s Digital CSR Donation Management System, an online portal used to receive proposals and coordinate reporting and monitoring of ongoing projects. Develop contents to demonstrate Global CSR Program partners’ impact using data, and collaborate closely with corporate communications teams to help develop regular and ad hoc project communications for internal and external audiences. Lead coordination of employee participation programs, online and onsite, to create learning and engagement opportunities for employees and support other employee engagement activities as part of the team. Support to Global CSR Program Request for Proposal (RFP) process, including serving as a proposal reviewer, with particular attention on evaluating applicant and shortlisted proposal budgets, and supporting the proposal budget and narrative clarification process, due diligence process, and donation agreement completion and awarding process with internal partners and awardees (as needed). Contribute to the design and drafting of research findings, publications, project updates, tool kits, guidance documents, presentations, and reports, as needed. Assist in the development of project communications for leadership. Support the Head of Global CSR to pursue opportunities for collaboration with other internal teams, helping to build a cross-cutting approach to global health work. Support the Global CSR team with additional tasks as needed. We are seeking a highly motivated, results-oriented individual with strong problem solving and analytical skills to support the Global CSR Program. This role entails working with an entrepreneurial, self-motivated mind-set. The candidate must be able to function independently, be flexible, and have strong commitment to excellence. This will involve attending calls and meetings with leadership, tracking action items and requests, and developing technical materials as needed for meetings and presentations, partnering with others internally and externally to resource various activities and ensuring appropriate follow up. We strive for a strong team environment, working in tandem with internal stakeholders within the enterprise, from finance and legal to corporate communications teams to execute our Global CSR Program. The Manager is a critical member of Global CSR’s lean, agile and dynamic team. A successful candidate will have a background/ interest in global health and philanthropy, be proactive and detail oriented with exceptional organizational, problem-solving, decision-making, analytical and communication skills. This role will rely on strong skills in building collaborations, partnering with broad stakeholder groups, working across global projects and teams, result management, clear communication (verbal and written), and strong time and people management. This role will also require using and embracing of data and technology. A successful candidate will be required to develop strong relationships with a variety of stakeholders, internal and external partners, and effective interactions with senior audiences. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise We seek experienced professionals with a Bachelor’s degree and at least 5+ years of experience, preferably leading projects with expanding scopes of responsibility. Relevant work experience in roles focused on developing, implementing, and managing projects/programs. Broad understanding of global health/development issues and some global health/development experience is preferable. Experience in philanthropic grant management is a plus. Leadership Capable of influencing without ultimate decision-making authority, and gaining buy-in from various stakeholders to ensure successful implementation of programs. Able to understand all the shifting components of a project and what each entails while keeping the big picture front and center Demonstrated strength in structured problem solving, with the ability to easily identify and communicate frameworks to facilitate decision-making. Ability to work in a self-guided manner, and manage multiple priorities with demanding timelines. Ability to question and challenge colleagues including managers and partners in constructive manner. Accustomed to highly unstructured and ambiguous situations; ability to proactively resolve. Interaction Interacts with ease and appropriate discretion with key internal & external stakeholders (members and senior leaders in Global Corporate Affaurs, in other Business Units / Functions and senior representatives of non-government organizations, etc.) Innovation Demonstrated ability to think creatively to ensure successful management of results and completion of programs/ projects. Demonstrated ability to translate strategic and technical content from conversations into high-quality presentations and written communications in the framing and voice of a principal. Ability to think creatively to help organize information, manage workflow, and improve systems and processes. Ability to embrace data and technology Complexity An ability to execute efficiently across a wide variety of tasks and projects simultaneously. Excellent organizational, facilitation, oral, and written communication skills. Ability to work effectively and with sensitivity across barriers such as language, culture and distance. Excellent listening skills and compassion.

【職務内容】 ・事業計画に基づく臨床開発戦略の立案 ・GCP SOP や関連書類の管理、教育 ・リソースと予算の最適化 ・営業部門の予算管理ならびに案件獲得に向けた営業戦略の立案 ・将来的に新規事業の立ち上げやM＆Aの促進など会社経営に関わる業務もお任せ致します。