Job Overview: The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assure the implementation of project
Company Description PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering
Company Description We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Role Summary The clinician contributes towards providing medical and scientific expertise and oversight for Clinical Trials conducted worldwide with a primary focus in Japan and the Asia-Pacific region. The clinician may be required to design a
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
General Information Job Advert Title: Clinical Site Manager II（早期フェーズ/臨床開発モニター/Site Monitor/CRA） Location: Nihonbashi,Tokyo Division: Early Development and Translational Science Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into
When our values align, theres no limit to what we can achieve. At Parexel, we all share the same goal - to improve the worlds health. From clinical trials to regulatory, consulting, and market access, every
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put
Basic purpose of the job enior CPhL-Asia supports the clinical development in Asia of new drugs and further development of approved drugs with emphasis on the design and execution of the Clinical Pharmacology (CP)development strategy. CPhL-Asia
Job Description 期待される役割と業務内容： 臨床開発プロジェクトの以下の業務の実行又はサポート 臨床開発戦略策定 早期開発戦略及び承認申請までの製剤開発を含む臨床薬理開発領域の戦略の考案 開発戦略に基づいた臨床薬理領域のPMDA相談資料の作成及び照会事項に対する回答作成 臨床薬理試験に関する以下の業務 治験実施計画書の作成 同意説明文書（案）の作成 治験実施計画書に関連する資料（症例報告書、関連手順書等）の作成、サポート及びレビュー 治験に必要な資料及び資材の準備やベンダー（国内外）との交渉 治験データのメディカルレビュー 治験総括報告書の作成（関係部署と協働） 承認申請に関する以下の業務 承認申請資料（CTD）の臨床薬理パートの作成 承認申請後の臨床薬理に関する照会事項に対する回答作成 必須条件： 医薬品臨床開発業務の経験（3年～15年程度） 社内（国内・外）関連部門及び外部機関との協働作業のためのコミュニケーションスキル 英語力（メール、電話及び会議で、米国本社及び海外ベンダーへの説明・説得及び情報聞き取りができる） 薬学又は生命科学に関する専門知識 望ましい条件： 臨床薬理開発業務の経験 治験実施計画書、CTD及び治験総括報告書作成、当局照会事項対応 CRA又はStudy management等業務の経験 今回の募集は、R2（Scientist）、R3（Sr. Scientist）または、R4（Associate Principal Scientist）での採用となる予定です。 応募の際にはカバーレターと応募書類（履歴書・職務経歴書）を添付してください。 Required Skills: Adaptability, Clinical Development,
Basic Purpose of the Job The Clinical Trial Manager (CTM) is accountable for the operational and scientific oversight, set-up, execution and delivery of assigned clinical trials at the Japan level. Key responsibilities: Accurate planning and efficient
Business IntroductionAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining
Job Overview: The Clinical Trial Manager II has ownership in the clinical delivery and operational oversight of clinical research trials. This role collaborates with project managers and other functional leads to deliver clinical and start-up activities
Job Purpose Supports the complete clinical/pharmaceutical drug life cycle process (research, development, market access, market supply) by providing strategic planning and execution, including data transformation and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
Sr. Site Management Associate ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives
Summary of purpose/major responsibilities The Clinical Operations and Study Leader (COSL) combines Clinical project and study oversight roles and responsibilities for Vaccines projects activities. For projects activities (project and study oversight, CTD submission, PAI…), the COSL