グローバルバイオファーマR&Dで臨床試験運用をリード|ビジネス英語+日本語必須。臨床デリバリーチーム(SM/CTM/CRA等)のリードと成果管理、ICH-GCP/J-GCP、ローカル規制に則った試験運用などを行う。 · ...

MonoxerのProduct Managerとして、プロダクトがより多くの方に価値を届けられるようにするためのリードをご担当いただきます。 · ...

+モニタリング業務(全て又は一部)の実施及び管理を行っていただきます。契約事項、GCP、SOP、その他関連する法規制等を遵守し、受託したプロジェクトにおけるモニタリング業務全般の実施、またその業務全般の管理を行う責務を担っていただきます。 · +育児休暇制度/介護休職制度/財形貯蓄/その他制度/確定拠出年金401k/社員持株会制度 · +OncologyおよびGlobalStudy経験がある方 · ・他社CROあるいはメーカーにて、CTLないしは同種の業務の実績がある方 · ・GlobalStudyのLSM経験、もしくは製薬会社で試験計画の企画立案経驗を ...

The Japan Study Manager is responsible for in-country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution. · In country study/site management and clinical/scientific oversight activiti ...

We are currently seeking a full-time RSP (Randomization & Study Product) Coordinator to join our team in Japan. · ...

+This role involves managing clinical trials in Japan including study start-up through database release and inspection readiness to ensure timely delivery of quality study data. · +

Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. · Res ...

The Study Management Associate III will be part of a dynamic team responsible for executing global clinical trials · Supports the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables · Vendor ...

We are seeking a Project Manager to accelerate clinical trial delivery and help bring new treatments to patients faster. As a Project Lead in Cronos Study Operations, you will be part of a core project team responsible for executing clinical studies. ...

We are seeking a full-time RSP Coordinator to join our team in Japan. · Responsibilities:General Randomization & Study Product Management support; · Study product management; · Assist the Project Manager in system design and set-up; · Work with clients in obtaining requirements a ...

Responsible for in country study/site management and clinical/scientific oversight activities of assigned clinical trials to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and Pfizer standards. · ...

Manage study sites in Japan, ensuring patient safety and quality execution of clinical trials. Collaborate with CROs and Pfizer standards. · ...

The Senior Specialist or Manager of Study Execution Team, Evidence Solution Group. Medical is responsible for on-time study execution upon regulatory Post Marketing Observational Studies (reg-PMOS) and non-regulatory non-interventional studies. · Work as a study manager according ...

日本におけるすべての臨床オペレーション機能をアセットレベルで代表する役割を担い、グローバルCOLと連携しながら、アセットおよび関連試験に対する科学的戦略を実行するためのオペレーション戦略および実行計画の策定を担当していただきます。 · ...

¡El Clinical Operation Project Manager es una posición clave para apoyar la estrategia de desarrollo en Japón! Se requiere experiencia en Clinical PM, Study Manager, Clinical Operations, así como habilidades en comunicación y conocimientos de inglés. Se ofrece un salario anual en ...

クリニカルリサーチマネージャーとしての募集となりますが、入社後数年の経験の後、ご本人のキャリア志向も踏まえて、将来は柔軟に広く社内の様々な部署で活躍していくことも可能となります。 · ...

For studies, ensure the set up and the progress of the clinical studies under responsibility, in accordance with local regulations, Good Clinical Practices, internal procedures, technical protocols. · Conduct, arrange and provide the documents for the PMDA consultation in collabo ...

This role involves managing clinical studies under responsibility in accordance with local regulations Good Clinical Practices internal procedures technical protocols. · Conduct arrange provide documents PMDA consultation collaboration WRAJRAPerform countrycentre feasibility prop ...

+Execute bioequivalence studies pharmacodynamic studies clinical endpoint studies healthy subjects patients accordance GCP regulatory requirements assistance Manager Vender Management documents PMDA consultation collaboration local regulatory affairs global team prepare submissio ...

We are seeking a Clinical Research Associate I to join our team. The successful candidate will be responsible for site monitoring and management, ensuring the integrity of clinical trial data and compliance with regulatory guidelines. ...

The Clinical Research Associate II will be responsible for site management of clinical studies according to Fortrea's Standard Operating Procedures and ICH GCP Guidelines. · ...