( 概要 ) 日本国内で治験を実施するためのオペレーションチームリーダーとして,国内外のステークホルダーとの協議•交渉など,エキスパートとしてのコミュニケーションを通じ,品質を確保した臨床試験を計画通りに遂行する。 ( 具体的な業務例 ) •試験実施施設の選定戦略,症例組み入れプラン•戦略の作成及び実行 •試験遂行のための現場の責任者としてモニターへの指示及びモニターへの助言 •試験全体の進捗および GCP , SOP に沿った臨床試験の実施と品質の確保 •国際共同試験の場合,海外担当者からの指示の正確な把握及び協議を含めた円滑なコミュニケーション •試験における Risk & Issue Management •治験契約締結交渉,データ固定, GCP • SOP に基づくモニタリングに対するモニターへのフォロー •チームビルディング,ステークホルダーマネジメントによるチーム作り •社内の改善活動 / Task force team への参加 •試験全体の予算の管理 Position Summary: The
Responsible for the coordination of post-sales activities associated with implementing and supporting customers. Work closely with client and internal resources to interpret client needs, ensure our product meets their needs and monitor project status. Keep client
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
Company Description Our Mission At Palo Alto Networks® everything starts and ends with our mission: Being the cybersecurity partner of choice, protecting our digital way of life. Our vision is a world where each day is
職務の目的および主な業務内容 Job Purpose & Key Responsibilities 職務の目的： 臨床試験の実施計画から実施完了まで、Timeline、Quality、BudgetにAccountabilityを持ち、Local studyの場合はStudy Delivery Lead (SDL) として、またGlobal studyの場合はLocal Delivery Lead (LDL)としてStudy Teamをリードし、臨床試験を推進する。 業務内容： 海外本社の関係部門（特にGlobal SDL）と密接な連携を取り、グローバルな視点で海外チームと日本でのOperation内容を合意した上で、国内関連部門との調整も行い、臨床試験の計画通りの遂行に責任を持つ。 開発戦略立案：日本での開発戦略の策定に参加し、Operationの視点でリスク評価、予定する試験のFeasibility調査及び予算算出を行う 臨床試験の運営：Study実施の具体的方針決定（各種Study levelでの意思決定）、Stakeholder management、被験者登録戦略の計画、CRO Oversight、Study Level問い合わせ対応、モニタリング報告書承認、Budget/Timeline/Study riskの管理 業務全般及び組織運営にかかわる以下の活動を担う。 各プロジェクトのSDL/LDLとの協働し、部内の業務遂行能力（専門的技能・知識等）の向上を担う（組織開発、人財育成） 必要要件 Required Skill, Experience, Etc. 必要な条件Basic Qualification スキル／知識
Job Description Technical Services Manager (Japan) At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life – To enable our
* The Safety Management Officer will oversee all safety management and pharmacovigilance (PV) activities in Japan. * This role involves ensuring compliance with local regulations, managing risk, and maintaining high standards of safety for all products. Client
* As a registered safety management supervisor required by Japan GVP, oversee and ensure overall safety related tasks for marketed products 企業情報 * Global Biotech company * Great pipeline with steady business status 職務内容 * Ensure
Leading the local trial team to deliver results compliant with assigned protocols, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. Actively contributing to process improvement and site management, you will train and
Lead in RA activities to obtain regulatory approval for company products. Expand the business into the Japanese market. Client Details * Global cosmetic medical device company * Specializing laser treatment for skin treatment * year on
As a Senior HR Manager you will drive HR initiatives and support expansion efforts in Japan - using your deep understanding of HR practices, excellent communication skills in both Japanese and English, and a proven track
An exciting opportunity as an Operation Specialist at a leading global logistics company. Some of the responsibilities involve order processing of Shippers Own Tanks (Round-Trip Operations) and handling of import and export orders for local customers. Client
You will be tasked with maintaining the existing ESG data set by handling incoming data inquiries from internal stakeholders and ensuring data quality by running multiple Quality projects. You will be supporting the ESG data set
Looking for new challenges and rewarding career? Join PageGroup! We take pride in our quality of our service and working culture. Working with us also provide you the opportunity to work with Tier 1 companies in
Are you ready to be part of the worlds leading tech company with a vision to create a safer online space? Join the company as their Junior Accountant and oversee every facet of the local accounting operations.
* Regulatory reporting mainly for bank entity * Liaison with regulators as well as tax authorities and auditors * Collaborate with local and overseas finance members Client Details Global bank is seeking a seasoned finance professional to
As a Junior HRBP you will play a pivotal role in supporting HR strategies with business objectives. As a strategic advisor and consultant, you will collaborate with business leaders and Senior HRBP to address people, organizational,
* Manage projects that will serve to increase productivity, efficiency, and profitability for the Supply Chain function * Partner with stakeholders and operational teams to spearhead strategic projects that aim to improve logistics operations and digitalize
The Financial Controller for this position oversees the accuracy of financial information in compliance with both local regulations and company standards, prioritizing asset protection. You will manage the planning, analysis, and reporting processes while actively promoting a
Global Enterprise Partners is looking for a IT Infrastructure Project Delivery/Manager to join my client in the FMCG industry here in Tokyo, Japan. This role is hybrid working style so this person must be located in
