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 。
About Mitsogo Mitsogo is a global organization that highly values the contributions of each employee. Our ability to attract top talent is a testament to our commitment to fostering a sense of belonging for everyone. We
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
The Group You’ll Be A Part Of The Customer Support Business Group focuses on enabling our customers with premier customer support throughout their lifecycle with Lam. We drive performance, productivity, safety, and quality of customers installed base
Location: Tokyo, Tokyo, Japan Job ID: R0052337 Date Posted: 2024-05-29 Company Name: HITACHI ENERGY JAPAN, LTD. Profession (Job Category): Legal, Compliance & Audit Job Schedule: Full time Remote: No Job Description: General information: You are expected
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
WHO ARE WE LOOKING FOR? We are looking for a Lead Nike Direct Digital Commerce (NDDC) Key Performance Indicator (KPI) Planner as part of the Demand & Supply Management (DSM) organization to shape and refine Quarterly/ Monthly/ Daily
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
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
Acronis is a world leader in cyber protection—empowering people by providing them with cutting-edge technology that enables them to monitor, control, and protect the data that their businesses and lives depend on. We are looking for
About Us Diligent is the global leader in modern governance, providing SaaS solutions across governance, risk, compliance, audit and ESG. Empowering more than 1 million users and 700,000 board members and leaders with a holistic view
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
Detailed Responsibilities -Working as leadership support to provide effective service delivery of end-to-end process of Supply Chain Customer Products to our internal or external customers globally. -Working closely with the IT Infrastructure and Operations leaders/teams/service providers,
This role required candidate to permanently relocate at Jubail, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
Custom-Bilt Metals JOB TITLE:Outside Sales Representative Location:Chino, CA Reports to:Vice President of Operations Status:Exempt - - - - - - - - - - - - - - - - - - - - - -
This role required candidate to permanently relocate at Riyadh, Saudi Arabia. About the Company Founded in the late 1970s in Saudi Arabias oil-rich region, this multinational corporation has solidified its position as a global leader in
Social Discovery Group (SDG) is a global technology company that builds apps at the intersection of dating, social, and entertainment. The companys portfolio includes 70 social discovery platforms with a focus on AI, game mechanics, and