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 社内関係者、および臨床試験チームからインプットをもらい、期限内にサンプル輸送ができる体制を整える 。
Cybereasons mission is to ‘protect it all’ – delivering unparalleled prevention, detection, investigation, and response for all endpoints: workstations, laptops, mobile devices and more Our cyber-defence solutions combine machine learning and AI to analyze threats, connecting
Our Enterprise Customer Success Manager (CSM)’s works closely with customers to discover their business needs and then coach them on the best way to use Tricentis testing tools in order to obtain business value and exceed
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: At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. Responsible Growth is how we run our company and how we
At Tridge, you will join a multicultural and diverse team of ambitious, caring, and results-driven individuals, all with one shared mission of empowering tomorrow. We currently have more than 300 staff working across more than 70
Mujin has transformed the field of industrial automation with its innovative robot control technology and is currently revolutionizing supply chains worldwide. Today, we are rapidly expanding our business both domestically and internationally, serving clients from Japan
Acquia empowers the world’s most ambitious brands to create digital customer experiences that matter. With open source Drupal at its core, the Acquia Digital Experience Platform (DXP) enables marketers, developers, and IT operations teams at thousands
Mujin has transformed the field of industrial automation with its innovative robot control technology and is currently revolutionizing supply chains worldwide. Today, we are rapidly expanding our business both domestically and internationally, serving clients from Japan
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
【Job Purpose】 Sales & Business Development Manager is expected to drive and execute sales objectives by improving the existing programs, winning new programs to implement and developing new businesses, and attain the assigned financial goals such
Job ID:39314 Lloyd’s Register Location: Japan / Malaysia / Singapore What we’re looking for A Technical Key Account Manager (TKAM) who contributes to providing support to our clients in the resolution of their technical queries and
Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our
Are you passionate about delivering outstanding service to clients across the region? Then, this is your opportunity to join the Fund Services Operations team under Securities Services Operations, assuming a key role in the successful managing
Job Summary As project team manager, you will be responsible for managing Japan project management team while improving project management business process. In this position, you will have the opportunity to provide insight encourage the tam
Consumer Marketing 担当 / Consumer Marketing - Core Printing Description - ◆業務内容: コアプリンタービジネス(ホームプリンター等)を中心としたコンシューマーマーケティングを 担っていただきます。 <具体的には> ・Core Printingビジネスの様々なMarketing(デジタルマーケティングや従来の広告施策等)戦略立案、実行 ・国内外の他部署(セールス、製品部等)と協業しJapanのCore Printingマーケティング担当として業務を遂行する ・オンライン広告出稿に関する立案、実行、ROI分析等 ・市場分析、顧客分析、競合企業分析等 下記経験がなくても「コンシューマーマーケティングの経験を積みたい」「外資系マーケティングの スキルを身につけたい」など積極的にチャレンジしたい方歓迎です! <求める要件> ・オンライン広告に関する経験、知見 ・ECビジネス経験があれば尚可 ・Marketing経験があれば尚可 ・英語でメール、Chat、ミーティング対応が可能な方(流暢ではなくてもOK) *今後、英語スキルを伸ばして行きたい方歓迎です。 ・ビジネスの状況から必要なStrategyを導き出すCritical Thinkingスキル ・社内の他部署や、APJチームとバーチャルで協業できる方 ・新しいやり方やビジネス状況の急激な変化に対応できる柔軟さ Singaporeとのやり取りも多く、フラットな組織であるため、外資系Marketingに求められる ビジネススキルが身に付きます。 ECビジネスの経験、コンシューマー向けマーケティング経験を得ることができます。
職務内容 Key Accountabilities Country Quality System management Lead the implementation and maintenance of GxP quality system with respective operation units, the continues quality system implementation for competencies and related Quality documentation of GxP area: medical, pharmacovigilance,
Job Description Summary -Equipment Operator -Execute assigned manufacturing tasks and activities according to production schedule to enable the timely production of product with the quality and quantity in compliance with the relevant GMP, safety and environmental
Job Description Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical
JOB SUMMARY Helps drive company values and philosophy and ensures all training and development activities are strategically linked to the organization’s mission and vision. Works with property leadership team to identify and address employee and organizational