Job Description Summary ノバルティスのプロセス、規制および倫理的要件に準拠し、薬物動態、バイオマーカー、安全性等に関わる生体試料の収集に関して、臨床試験へ実装し、臨床試験開始から終了までのOperationを担当します。また、コンパニオン診断に関連する業務についてもサポートする場合があります。 Job Description Major Accountabilities Lead Clinical Biospecimen Scientist(CBS)の監督下、社内関係者と協働し、戦略に基づき、臨床試験における生体試料に関する技術面・Operationに関連する業務を実行する。主に以下の業務を実施する。 - 臨床試験関連文書（治験実施計画書や同意説明文書など）の臨床評価項目に情報を提供する。 - 臨床試験固有のサンプル収集表を作成する。また、ラボマニュアルなどの関連文書も含め、ラボキットの作成、サンプルの管理、検査会社（Laboratory）に対して技術的側面を管理する。 - 生体試料のライフサイクル全体を通じて、サンプル管理（処分含む）、輸送を担当する。社内関係者および検査解析会社（Laboratory）と協働し、症例報告書（CRF）とデータ転送に関する要件を定義し、 タイムリーな分析、転送されたデータの品質を担保する。 Risk management: 社内関係者と協力し、生体試料の収集および分析に関連する臨床試験固有のリスクおよび問題を適切に報告する。 Resource management: Lead CBSの監督の下、Vendor managerおよびProcurementと協力して、検査会社（Laboratory）からの提案、予算情報、および請求書の確認をおこなう。 担当臨床試験および担当プログラムにおいて、標準業務手順書（SOP）を遵守し、Lessen and Learnなどを通じて最良の結果を求める。 Key Performance Indicators GCP, SOP, ICH等の遵守
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Description Summary -Provide timely & professional ongoing Mgmt of Data Mgmt/Coding/CDDRA-Database Development/DAP deliverables and of clinical trial data with respect to cost, quality and timelines for all assigned trials within Clinical Data Mgmt. Ensure consistently
Medical Manager Location: Japan About the job At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately,challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves,
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee youll be
The Role: Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, youll be
This is what you will do: The Launch Planning Lead will drive projects, generate insights, and make recommendations that will enable compliant, efficient, and effective execution of product launch preparation across Alexion’s portfolio to support successful
■ 職務内容 / Job Description Job purpose In alignment with AZKK’s stated goal of being #1 by 2025, Information and Digital Solutions (“IDS”) is playing a key role providing thought leadership and key digital and technological
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Job Description Summary -Lead the country Franchise Medical Team, develop the Franchise Medical Strategy and executes it through and operational Medical Plan. Coach and develop team members as well as represent Medical in country Franchise Leadership
Job Description [Position/ ポジション名] 渉外本部 Public Affairs Manager [Responsibilities/ 職務内容] Public Affairs Manager implements the business strategy, engagement, and activation of external stakeholders who drive or influence the policies that determine our ability to successfully secure
Join an innovative biopharmaceutical company dedicated to pioneering advancements in healthcare. Our client is seeking a dynamic and experienced Cardiovascular Product Manager to lead our in developing and executing marketing strategies for their new cardiovascular product
* We are seeking a fluent Japanese and business-level English-speaking EDC System Implementation Specialist with clinical programming expertise to join our biometrics specialized CRO client, partnering with Japanese pharmaceutical companies. This remote role offers a competitive salary
As a clinical trial manager, you oversee the planning, execution, and monitoring of clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements while collaborating closely with cross-functional teams to drive successful trial completion and contribute
Our client is a large US pharmaceutical business. They are looking for candidate with 5 years experience in data analytic/ data scientist background to join them. Client Details Our client is an international pharmaceutical company based in US.
* Create and lead Evidence Generation Plan * X-functional position understanding strategies of Medical / Commercial / R&D Client Details * Global pharmaceutical company * Pioneer and Leader in RWE, observational research study design and execution Description
Leverage your fluency in Japanese and business-level English to develop and manage high-quality proposals for global clinical research projects. Contribute to groundbreaking medical advancements in a dynamic, collaborative environment while enjoying competitive compensation and professional growth
