Job Description
- Review and evaluate non-clinical/ clinical data
- Plan clinical development strategy with assistance from manager and global team
- Prepare documents for PMDA consultation in collaboration with local regulatory affairs and global team
- Execute and report bioequivalence studies, pharmacodynamic studies and clinical endpoint studies with healthy subjects and patients in accordance with GCP and other regulatory requirements with assistance from Manager
- Vender Management with assistance from manager
- Prepare submission dossier non-clinical and clinical part with assistance from manager and global team
- Prepare answers to deficiency letters from PMDA with assistance from manager and global team
- Management and archive relevant documents
- Support market team after getting approval with assistance from manager
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Tokyo Sandoz ¥8,000,000 - ¥14,000,000 per year+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 ...
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Tokyo Hays臨床研究サイトおよび臨床試験参加に関する患者データおよび研究関連情報を監視します。調査員が研究プロトコル、規制要件、良好な臨床慣行に従い、データ検証計画への入力を提供します。患者データのタイムリーかつ正確なモニタリングと、ソースドキュメント、研究記録、およびサイト訪問から、必要に応じて調査関連情報を提供します。 · 調査サイトおよび監査施設の選択を監視します。 · 臨床試験を実施する能力を評価するために、潜在的なサイトのサイト選択を実施します。 · さまざまな問題を解決するための会社の方針と手順を適用します。 · コスト センターの目標と目標に貢献します ...
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Tokyo Intuitive ¥3,000,000 - ¥9,000,000 per yearダビンチサージカルシステムの稼働率を最大化する責務を担い、各地域の市場に合わせたコンサルティング型の営業活動を実施し、新製品の紹介や消耗品等の販売を行う。 · 主要な手術手技におけるダビンチ手術の専門家として、手術チームの「パートナー」としての地位を確立する。 · ...
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Tokyo Sandoz ¥3,000,000 - ¥6,000,000 per yearThis job involves reviewing and evaluating non-clinical data, planning clinical development strategy, and executing bioequivalence studies. · Review and evaluate non-clinical/clinical data · Plan clinical development strategy with assistance from manager and global team · ...
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Tokyo Hays臨床研究サイトおよび臨床試験参加に関する患者データおよび研究関連情報を監視します。調査員が研究プロトコル、規制要件、良好な臨床慣行に従い、データ検証計画への入力を提供します。患者データのタイムリーかつ正確なモニタリングと、ソースドキュメント、研究記録、およびサイト訪問から、必要に応じて調査関連情報を提供します。 · 臨床試験を実施する能力を評価するために、潜在的なサイトのサイト選択を実施します。 · サイト開始訪問を実行し、サイトのスタッフがすべての試験関連の側面に完全に訓練されていることを確認します · さまざまな問題を解決するための会社の方針と手順を ...
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Japan, Tokyo IRE ¥520,000 - ¥1,168,000 per yearClinical Site Associate role at ICON plc in Tokyo Osaka with office hybrid setup. ...
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Japan, Tokyo IRE ¥500,000 - ¥1,200,000 per yearClinical Site Associate - Office Hybrid role at ICON plc in Tokyo Osaka, fostering an inclusive environment driving innovation and excellence. · Competitive salary and benefits package. · Diverse culture that rewards high performance and nurtures talent. · ...
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Tokyo, Tokyo Deep Intelligent Pharma ¥1,800,000 - ¥2,500,000 per yearDeep Intelligent Pharma is pioneering the transformation of the pharmaceutical industry with a revolutionary AI-native, multi-agent platform. Our mission is to empower pharmaceutical and medtech innovators by turning regulatory and clinical complexity into a catalyst for speed, s ...
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Tokyo Medpace ¥2,500,000 - ¥6,000,000 per yearWe are seeking a Associate Clinical Trial Manager to join our Clinical Trial Management team in Tokyo. The ideal candidate will have a PhD in Life Sciences and/or Post-Doctoral Research experience, with excellent analytical and academic skills. They should be able to transfer and ...
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Japan - Tokyo Gilead Sciences ¥5,000,000 - ¥15,000,000 per yearWe are seeking an Associate Director, Clinical Development to play a key role in the scientific planning, execution and reporting of Japanese clinical studies for Gilead's development compounds in inflammation and virology therapeutic area. · ...
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Tokyo, Tokyo PSI CRO ¥900,000 - ¥1,200,000 per yearWe are searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Japan. · Conduct and report all types of onsite monitoring visits · Be involved in study startup · Perform CRF review, source document verification and que ...
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Tokyo, Japan PSI CRO ¥4,000,000 - ¥6,000,000 per yearWe're searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Japan. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical ...
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Tokyo, Japan PSI CRO ¥4,500,000 - ¥6,500,000 per yearWe are seeking a Senior Clinical Research Associate I to work on the frontline of communication with project stakeholders, ensuring timelines, targets. You will have the opportunity to work on clinical studies in various therapeutic areas and indications while maintaining the hig ...
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Japan PROCEPT BioRobotics ¥9,000,000 - ¥12,000,000 per yearThe Clinical Associate Representative will provide technical and clinical support for the AQUABEAM Robotic System and provide surgeon and staff training, in-service support, and clinical assistance for existing and potential customers. · Provides medical professionals with produc ...
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Japan Heidi ¥4,000,000 - ¥12,000,000 per yearAs a Growth Associate at Heidi Health, you are empowered to establish and scale Heidi Health's presence in Asia, out of Japan from the ground up. You are responsible for developing a leading and sustainable market position - not by following a predefined playbook, but by creating ...
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Japan BeiGene ¥6,000,000 - ¥12,000,000 per yearWe are seeking a Clinical Research Associate II/Senior Clinical Research Associate to join our team. As a key member of our organization, you will be responsible for executing clinical trial protocols at clinical trial sites and monitoring clinical trials by ICH guidelines and GC ...
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Ebisu, Tokyo Teva Pharmaceuticals ¥2,000,000 - ¥2,500,000 per yearAssociate Director, Clinical Project Management - Japan is responsible to plan, lead and oversee the operational execution of Teva's clinical programs in Japan across all indications from Phase I to Phase IV, in terms of cost, quality, timeliness and efficiency, while assuring pa ...
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Tokyo ICON plc ¥420,000 - ¥840,000 per yearClinical Site Associate in Tokyo Osaka - Office Hybrid at ICON plc, a world-leading healthcare intelligence and clinical research organization. · ...
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Tokyo Heidi ¥800,000 - ¥2,000,000 per year+Job summary · A Clinical Growth Associate at Heidi Health will establish and scale Heidi Health's presence in Asia from scratch. · +ResponsibilitiesOwning the success of Heidi Health across Asia. · Developing market leadership through full-cycle execution. · ...
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Tokyo Medpace ¥3,600,000 - ¥6,000,000 per yearJoin our growing team as a Clinical Research Associate and receive training to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to benefit from unique incentive programs with a competitive salary and career growth potential ...
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Minato Novartis ¥4,000,000 - ¥6,000,000 per yearClinical Research Associate monitors patient data and research-related information at clinical research sites and clinical trials. Investigator provides input to data validation plans in accordance with research protocols, regulatory requirements, and good clinical practices. Pro ...