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Jobs list of Pharmaceutical & Clinical Development

51 jobs
Showing 1-20 of search results
  • NEW
    Job number: JN -072024-143282 Posted: 2025-03-28

    [Osaka or Tokyo] Clinical Team Manager

    Strong Global Foot Print and High Salary
    9 - 15 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is the Japanese subsidiary of a European CRO with over 100 offices and tens of thousands of employees worldwide.
    We have a strong business foundation providing global drug development services and a vision to be a “Global Healthcare Intelligence Partner”. We aim to provide advanced drug development operations by combining our experience in drug development with technology that enables 100% virtual clinical trials.

    As a partner to pharmaceutical manufacturers and bio-venture companies, we provide a wide range of support from clinical trials to regulatory filings and post-marketing activities. We can also provide a comprehensive range of services including regulatory affairs, pharmacovigilance, and medical writing.
    We have a culture where employees work healthy and enjoy challenges, and have been awarded “World\'s Best Company” multiple times by Forbes, an American economic magazine.
    Responsibilities
    BUILD RELATIONSHIPS WITH CLIENTS AND LEAD
    PROJECTS BY COLLABORATING WITH PROJECT MANAGER (GLOBAL PM OR REGIONAL / LOCAL PM) AND OTHER DEPARTMENTS (INCLUDING PARTNER VENDORS) AS NEEDED -CRA FOR EACH PROJECT, IN-HOUSE CRA, PROJECT LEADS SUCH AS CONTRACTS ASSOCIATE AND START-UP LEAD
    MANAGEMENT OF QUALITY, TIMELINE, AND BUDGET IN MONITORING
    PROACTIVE RISK MANAGEMENT
    CONTRIBUTING TO GROWTH WITH APPROPRIATE GUIDANCE TO INEXPERIENCED MEMBERS
    Patrick Chang
    Patrick Chang
    Pharma
  • NEW
    Job number: JN -112024-179804 Posted: 2025-03-28

    臨床開発計画の立案を担うクリニカルサイエンスリーダー

    製薬メーカー等での臨床開発業務経験が活かせます。
    11.1 - 12.6 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.
    Responsibilities
    Immunology領域における臨床開発計画の立案(後期開発品における市場価値最大化の検討含む)
    臨床試験のプロトコルの策定
    当局相談資料や申請資料などRegulatory Agenciesとの対応と方針の決定
    国内外Key Opinion LeaderおよびRegulatory Agenciesとの折衝
    導入候補品の臨床科学的評価
    臨床試験の外部への発表に関する業務
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • NEW
    Job number: JN -072024-143741 Posted: 2025-03-28

    Senior Manager Clinical Research

    Global position
    12 - 18 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
    Responsibilities
    Create Japan clinical development plan within global development strategy
    Lead clinical studies in Japan from scientific perspective
    Lead PMDA consultation related to Japan clinical development
    Develop clinical study protocols
    Support development of other study-related materials (e.g. draft Informed Consent, Case Report Form, study related SOP, etc.)
    Support study operations
    Perform medical monitoring of clinical study data
    Develop Clinical Study Reports
    Lead clinical related part of approval review
    Develop clinical sections of the Common Technical Document (CTD)
    Develop responses for clinical related inquiries
    Make presentations at scientific meetings and/or author manuscripts on clinical trials, or provide necessary support for them
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • NEW
    Job number: JN -032025-185855 Posted: 2025-03-25

    【東京】プロジェクトマネージャー

    プロジェクトリーダー経験者必見です!
    7 - 10 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    -
    Responsibilities
    治験依頼者、並びに社内関係者と協働して、試験全体の管理をしていただきます。
    主な仕事は、治験依頼者のニーズに適した試験タイムラインに沿って治験を進めること、リソース調整や費用管理、進捗確認などとなります。
    グローバルチームや依頼者との窓口担当者としての責務も担い、様々な部門とコミュニケーションを計りながら、円滑なプロジェクト実施に取り組んでいただきます。
    業務詳細:
    グローバルチーム、治験依頼者並びに社内関連部門との窓口業務
    リソースの調整、費用の管理、進捗確認
    治験依頼者のニーズの確認及びサービスの提案
    プロジェクト下のピープルマネジメント(当社はLMがいないため、PMが兼務)
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -032025-185304 Posted: 2025-03-11

    【東京】添付文書情報課 ※パイプライン豊富なグローバル大手医薬品メーカー

    薬剤師資格お持ちの方歓迎
    5 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
    Responsibilities
    【職務内容】添付文書情報課のスタッフとして、以下の業務を担当していただきます。開発品および市販品の添付文書・患者向医薬品ガイドの作成及び改訂
    社内関連部署(研究開発部門、営業部門、生産部門、メディカルアフェアーズ、米国本社等)との調整およびレビュー
    PMDAとの添付文書改訂相談及び新規・改訂添付文書届出
    情報伝達方法及び公開時期に関する打合せ
    添付文書に関する外部問い合わせ対応

    【カルチャー/環境について】パイプラインに恵まれており、また外資の中では比較的穏やかな社風なので、じっくりキャリアを積むのには良い環境となっております。副業も認められており、ジョブポスティング制度によるキャリア形成も充実しております。フラットでスピーディーな組織体制となるべくアジャイル組織を導入するなど、働き方への変化へ非常に前向きな企業でございます。
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -032025-185321 Posted: 2025-03-11

    クリニカルリサーチマネジャー

    CROで Project Leader 等のご経験をお持ちの方必見です
    7 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people\'s health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.
    Responsibilities
    海外本社カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担う試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする
    チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる
    試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う
    CRA(CRO含む)の相談窓口として、施設レベルの課題を解決する
    試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する
    ※がん領域もしくはGeneral Medicineの領域で募集しておりま
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -072024-142427 Posted: 2025-03-03

    臨床開発戦略・薬事コンサルタント<再生医療分野>

    ニッチ分野で成長を続ける成長企業
    7 - 10 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is providing drug development service.
    Responsibilities
    再生医療分野における製品の上市を目的に、再生医療等製品(細胞加工、遺伝子治療)の開発に関する以下の業務を総合的に行う。
    開発戦略立案等に関するコンサルテーション業務
    RS相談、治験相談支援
    再生医療等製品臨床開発
    再生医療等製品開発体制構築支援

     
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-11730 Posted: 2025-03-03

    Clinical Lead/ Project Lead

    臨床開発の企画経験者必見です!
    6.5 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
    Responsibilities
    臨床開発プロジェクトのタイムラインの管理
    プロジェクトに関する提案、契約締結
    社内の調整・進捗管理(主に、プロジェクトメンバーとなるCTL、CRAなど)
    プロジェクトの予算管理・調整
    リスクマネジメントプランの作成
    開発戦略提案、ビッドへの参画、契約締結に向けた交渉
    開発他部門との調整、進捗管理
    グローバル治験/アジア治験においては、日本発信のプロジェクトをマネジメント
    他国CPMとの協業
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-13567 Posted: 2025-03-03

    リーダー候補 / 臨床開発・データマネージメント担当者

    製薬メーカーまたはCROでのデータマネジメント実務経験をお持ちの方必見です
    5.93 - 9.68 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We specialize in the research, development and manufacture of pharmaceutical products. We mainly provide therapeutic drugs for diseases of the cardiovascular system, bone and joint system, and nervous system, with the aim of improving the health and quality of life of patients. We are committed to creating new drugs and improving existing drugs by utilizing our advanced technological and R&D capabilities. We also set strict standards for product quality control to supply safe and effective medicines to the market. In collaboration with medical and research institutions in Japan and overseas, we also focus on developing treatments that incorporate cutting-edge medical technologies. With an emphasis on a patient-centered approach, we have established ourselves as a trusted pharmaceutical manufacturer.
    Responsibilities
    具体的には、以下の業務を臨床試験のデータマネージメント担当者として、多くの関係者と連携しながら遂行していただきます。(1)臨床試験立ち上げからデータベース固定・SDTM作成までのタイムラインの管理(2)国内外のデータマネジメントCROのオーバーサイト(3)DMP(Data Management Plan)等の各種DM関連資料のレビュー(4)電子データ申請対応および適合性調査対応(5)リスクベースドアプローチに基づくデータ品質確認手法のブラッシュアップ(6)ウェラブルデバイス、eCOA(electronic Clinical Outcome Assessment)など多様なデータ収集プロセスの導入検討
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-5291 Posted: 2025-03-03

    【東京】プロジェクトマネージャー

    製薬企業またはCROでグローバル試験のPM経験3年以上お持ちの方必見です。
    7 - 9.5 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is a Contract Research Organization (CRO).
    Responsibilities
    当社が実施するプロジェクトの進捗管理と適切な予算管理をお任せします。
    担当プロジェクトの課題や変更管理など、クライアントとの窓口責任者として様々な課題の解決に向けて社内外の調整をお任せします。
    国内とグローバル両方の標準手順を理解し、医薬品・医療機器等の試験チームのPM経験を積んでいただくことを期待しています。
    また顧客満足度の向上にむけて、さまざまは提案をしていただいたり、サービスプロバイダーとしてプロジェクトマネジメントの専門ノウハウを蓄積していくことも期待しています。
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-138039 Posted: 2025-03-03

    CRA/Senior CRA

    Both RA and Clinical work
    8 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Newly started domestic CRO, rapidly expanding in APAC and focusing on smaller to mid sized pharmaceutical companies looking to enter Japan/APAC
    Responsibilities
    Clinical Development Operations:
    Ensure that the trial sites are conducting the study/ project according to ICH-GCP, applicable SOPs and regulatory requirements and that subjects’ rights, safety and well-being are being protected.
    Primary point of contact of trial sites with regards to the conduct of the study/ project
    Perform site feasibility, site selection, initiation, monitoring and close-out visits according to the monitoring plan or scope of work
    Ensure that the sites are adequately trained on the protocol and other study specific requirements
    Write visit reports with the required information and ensure that this is finalized on a timely manner according to the monitoring plan
    Ensure that site contacts are adequately documented (e.g. through contact reports) and filed appropriately in the Trial Master File (TMF).
    Escalate issues to the CTM, Medical Monitor, Line Manager and/or Quality Assurance as necessary.
    Manage the progress of assigned studies/ sites by tracking regulatory submissions and approvals, recruitment and enrollment, electronic/case report form (e/CRF) completion and submission, and data query generation and resolution.
    Ensure adequate filing of study documents in the TMF and Investigator Site File (ISF)
    Track site budget and payments
    May be involved in preparation of status reports for clients
    Participate in Internal and External Meetings (such as Regular Project Teleconferences, Investigator Meetings, etc.) as necessary
    Act as mentor/coach to more junior staff as necessary
    Travel as necessary according to project needs
    Perform other duties as assigned by line manager.

    Regulatory:

    Ensure study start up processes are done according to applicable SOPs and regulatory requirements.
    Prepare and submit regulatory and clinical documents to Regulatory Agencies and Independent Ethics committee (IEC)/Institutional Review Board (IRB)
    Ensure that product labels are compliant with applicable regulatory requirements
    Collect and submit necessary documents for study drug importation, return and/ or destruction
    Ensure that all documents necessary for site activation are collected
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -092024-176371 Posted: 2025-03-03

    臨床開発職

    抗がん剤(固形がん・血液がん)における医薬品臨床開発のクリニカルサイエンス業務経験(3年以上)をお持ちの方必見です。
    6 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
    Responsibilities
    開発候補品の非臨床データの理解に加え、ターゲットの疾患情報や他社競合品情報などから、最適なFIH試験デザイン及びグローバル開発戦略を立案する。
    抗がん剤プロジェクトのクリニカルサイエンティストとして、プロトコール、同意説明文書の作成および改訂、メディカルライター等と協働して総括報告書の作成等を行うことで、グローバルスタディを推進する。
    新規試験を中心としたグローバル開発戦略立案、開発戦略・臨床試験計画策定のため医師・KOLと専門的な議論を行う。
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -072024-33887 Posted: 2025-03-03

    Clinical Research Associate/臨床開発モニター(東京・大阪・神戸・在宅可)

    Work on global projects at major CRO
    5 - 10 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a global leader in biopharmaceutical development based in the United States.
    Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
    Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.
    Responsibilities
    具体的には以下のような業務を遂行します。
    治験を実施する医療機関や医師の選定
    治験の依頼・契約
    治験薬の搬入及び回収
    モニタリング ・GCP(Good Clinical Practice)、治験実施計画書、SOP(Standard Operating Procedure)に則って治験が進んでいるかを確認
    直接閲覧(SDV: Source Data Verification)を実施し、症例報告書(CRF: Case Report Form)とカルテ等が一致しているかを照合し、回収
    IRB (Institutional Review Board)への文書提出及び手続き
    医療機関における保管必須文書が適切に保管されているか確認
    モニタリング報告書作成
    治験の終了手続き など

    Specifically, we will carry out the following tasks:
    Selection of medical institutions and doctors to conduct clinical trials
    Making requests and handling contracts
    Delivery and collection of investigational drugs
    Monitoring - Confirming whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
    Performing direct viewing (SDV: Source Data Verification), checking whether the case report form (CRF) matches medical records
    Document submission and procedures to IRB (Institutional Review Board)
    Confirming whether documents required to be kept at medical institutions are stored appropriately.
    Monitoring report creation
    Clinical trial termination procedures

     
    Yui Osone
    Yui Osone
    Pharma
  • Job number: JN -072024-6846 Posted: 2025-03-03

    Inexperienced CRA

    Inexperienced
    4.5 - 6.5 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a global leader in biopharmaceutical development based in the United States.
    Our client is a CRO giant, offering a wide range of services supporting clinical trials at every and all stages. They also provide specialized services for biotech-related clinical trials, leveraging their unique technology and industry expertise.
    Our services span the entire spectrum of clinical development, from planning and execution to monitoring and data management. Additionally, we offer advice on pharmaceutical regulation and market deployment, supporting clients through the process from drug approval to market entry.
    Responsibilities
    治験を実施する医療機関や医師の選定
    治験の依頼・契約
    治験薬の搬入及び回収
    モニタリング
    GCP、治験実施計画書、SOP に則って治験が進んでいるかを確認
    直接閲覧(SDV)を実施し、症例報告書とカルテ等が一致しているかを照合し、回収
    IRB(治験審査委員会)への文書提出及び手続き
    医療機関における保管必須文書が適切に保管されているか確認
    モニタリング報告書作成
    治験の終了手続き 等
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -102024-177490 Posted: 2025-03-03

    トランスレーショナルサイエンティスト

    オンコロジー領域における3年以上の薬理研究、あるいはトランスレーショナル研究経験と専門知識をお持ちの方必見です。
    6 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client a major Japanese pharmaceutical company engaged in the research, development, manufacturing, and sales of pharmaceuticals. Our group promotes four business areas—new drugs, generics, vaccines, and OTC products—to meet diverse medical needs. By expanding our operations globally, we aim to provide innovative treatments to a wide range of patients. Additionally, we possess advanced technological capabilities and well-equipped facilities to support our research and development. We actively conduct clinical trials both domestically and internationally, striving to demonstrate leadership in the pharmaceutical industry while emphasizing our commitment to contributing to society as a whole.
    Responsibilities
    グローバルトランスレーショナルサイエンスリーダーとして、サイエンティストと共同で、臨床開発戦略と整合したトランスレーショナルサイエンス全体戦略の策定・実行
    あるいは、グローバルトランスレーショナルサイエンスリーダーとの連携による担当癌種、臨床試験におけるトランスレーショナルサイエンス戦略策定と実行
    各種トランスレーショナルサイエンス関連業務の担当者・専門家との共同を通じた非臨床・臨床とトランスレーショナルサイエンスデータの解釈・成果物の創出
    プロジェクトチームへの戦略・成果物の説明、意思決定への貢献
    外部専門家との共同研究戦略策定の議論、方針決定、推進
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: JN -072024-143554 Posted: 2025-03-03

    Clinical Project Manager / Clinical Leader

    Global Trail and high salary
    8.5 - 17 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a global healthcare company and the largest provider of biopharmaceutical development and commercial outsourcing services. In today\'s rapidly changing environment surrounding the healthcare industry, we are making a significant contribution to the development of the industry through its four business segments: Clinical Development, Sales & Marketing, Investment & Alliances, and Consulting. The company, which has supported the development and commercialization of the top-selling drugs worldwide, plans to substantially increase the number of CRAs as it continues to increase projects in large-scale global studies, the anticancer field, the central nervous system field, and other rheumatology fields.
    Responsibilities
    Manage Clinical Trials
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-146306 Posted: 2025-03-03

    【東京】CTL(クリニカルチームリーダー)

    臨床開発のモニタリング経験者必見です!
    6 - 8 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
    Responsibilities
    治験実施計画書、同意説明文書及び症例報告書の作成(補助)
    モニタリング計画書等、各種手順書の作成
    モニタリングおよび施設対応の実施責任者として、モニターを指揮して治験を実施
    モニタリング報告書・必須文書・症例報告書等の確認
    担当試験に係わるチーム内(モニター)教育
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -072024-146307 Posted: 2025-03-03

    【東京】臨床開発プロジェクトマネージャー

    臨床開発プロジェクトマネージャー経験者必見です!
    6 - 9 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are committed to providing high-quality products and delivering appropriate safety information to patients and consumers worldwide. In our pharmaceutical business, we focus on developing anticancer drugs and other medications, offering treatments for cancer, immunology, allergies, and urology. Additionally, in our consumer healthcare business, we cultivate well-loved brands that contribute to the health and well-being of consumers over the long term.
    Responsibilities
    臨床開発プロジェクトのスケジュール・リソース・コスト管理
    社内意思決定プロセス管理
    関連部門(臨床開発、薬事、非臨床、CMC等)で構成されるプロジェクトチームのコミュニケーションマネジメント
    共同開発先・導出入先との協業プロジェクトのアライアンス業務
    歓迎条件:
    海外スタッフを含むグローバルチームでの業務経験
    上級レベルの英語コミュニケーション能力 (グローバルチーム会議をファシリテートできる会話能力)※海外拠点や海外他社協業先とのグローバルプロジェクトの担当機会あり
    抗がん剤領域の新薬開発経験
    プロジェクトマネジメント管理ソフトの使用経験(例:MS-Project、Planisware等)
    Project Management Professional (PMP)資格
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -012025-182483 Posted: 2025-03-03

    メディカルインフォメーション

    薬剤師資格もしくは理系修士以上をお持ちの方必見です。
    5 - 6.5 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is providing a variety of services to pharmaceutical and medical device companies and other healthcare companies.
    Responsibilities
    学術情報の収集、評価、集積
    社内に向けた戦略や資材作成、学術情報提供
    外部向け使用スライドの学術的検証

    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: JN -012025-182782 Posted: 2025-03-03

    統計解析(申請電子データ作成および提出)

    臨床試験の申請電子データ作成及び提出の実務経験5年以上お持ちの方必見です。
    6 - 9 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    Our client is a comprehensive scientific manufacturer.
    Responsibilities
    医薬品・医療機器(がん関連領域)の臨床試験の申請電子データ作成及び提出業務全般をお任せします。申請電子データ作成:SDTM 及び ADaM 関連仕様書、SDTM、ADaM、Define、ARM、Reviewer’s Guide 作成及びバリデーション
    導入先から入手した申請電子データの修正:SDTM、ADaM、Define、ARM、Reviewer’s Guide 修正及びバリデーション
    申請電子データ提出:m5 フォルダ作成、Gateway 提出サポート
    SAS プログラミング(データハンドリング、TFLs 作成等)
    作成ドキュメント類の Review
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
123

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