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Jobs list of Pharmaceutical & Clinical Development

43 jobs
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  • NEW
    Job number: Job-00222610 Posted: 2024-07-18

    早期臨床開発機能におけるクリニカルサイエンスリーダー(サイエンスの観点からのプロジェクトリーダー)

    医薬品臨床開発経験をお持ちの方必見です
    6 - 10 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
    Responsibilities
    医薬品の研究、開発、製造、販売および輸出入行う同社において、早期臨床開発機能におけるクリニカルサイエンスリーダーとして下記業務をお任せいたします。Pre-clinical StageからPoC取得までの早期ステージにおける、自社創製品の開発戦略策定/プロトコル立案等の責任者・グローバルにおける、適応疾患の検討及び選定グローバル開発戦略の策定(Wearable deviceの臨床試験への導入など、デジタル技術の活用検討を含む)
    開発段階に応じたTPP(Target Product Profile)の策定
    First in Human を含む、グローバル試験のプロトコル骨子の作成
    国内外の疾患領域の専門家との議論
    国内外における規制当局との戦略相談に向けた資料作成、照会回答作成、議論のリード
    治験データのメディカルデータレビュー
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00220681 Posted: 2024-06-20

    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: Job-00261383 Posted: 2024-05-22

    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: Job-00210481 Posted: 2024-05-21

    [Osaka & Tokyo] Clinical Research Associate (CRA) in Operation

    Rewarding Career, Global Development
    9 - 14 million yen Other Pharmaceutical Clinical Development

    Company overview
    In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
    Responsibilities
    MANAGE / MONITOR THE PROGRESS OF YOUR TRIAL ON-SITE OR OFF-SITE, AND CONDUCT, RECORD, AND REPORT YOUR TRIAL IN ACCORDANCE WITH CLINICAL TRIAL PROTOCOL, SOPS, ICH / J-GCP, AND OTHER APPLICABLE LAWS AND REGULATIONS. GUARANTEE THAT YOU ARE
    RESPONSIBLE FOR CONTRACT NEGOTIATIONS AND CONCLUSIONS WITH MEDICAL INSTITUTIONS
    WORK CLOSELY WITH OTHER CLINICAL TEAM MEMBERS TO TIMELY RESOLVE ANY CLINICAL TRIAL ISSUES THAT ARISE
    INEXPERIENCED GIVE APPROPRIATE GUIDANCE TO MEMBERS AND CONTRIBUTE TO THEIR GROWTH
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00188690 Posted: 2024-05-02

    Site Activation Specialist/In-House CRA

    グローバル臨床試験における契約交渉および費用交渉のご経験が活かせます!
    5 - 7 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
    Responsibilities
    【1】Site Activation業務Investigator recruitmentおよびfeasibility
    治験施設との臨床試験契約の交渉と継続的な管理。
    臨床試験実施における治験施設のタイムリーな立ち上げをサポートするための契約実行スケジュールの管理
    部門のガイドラインに基づき、社内外の関係者に法律や予算の問題を伝え、説明し、国特有の法律や規制が守られていることを確認
    クライアントの要求した契約変更をレビューし、評価し、部門のガイドラインに基づいて、適切に逸脱を報告
    契約書の完全性と正確性を評価し、部門のガイドラインに準拠しているかどうかを確認し、契約書を修正し、契約書変更のファイリング
    【2】In-House CRA業務被験者のscreening/enrollmentサポート
    CRFのチェックおよび回収サポート
    Clinical supply/service vendorsおよび社内関係チームとの連携
    CTMS等の使用による費用請求・支払の対応
    必須文書の収集・レビュー・管理およびclose-out
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00217938 Posted: 2024-04-10

    Clinical Trial Manager

    CTM
    8 - 10 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
    Responsibilities
    臨床試験マネージャーは、治験の開始からデータベース管理まで、臨床業務に従事していただきます。
    臨床試験における様々な側面を管理するマネージャーポジションです。
    他部門との連携が多数発生します(アメリカ拠点との英語コミュニケーション有)。
    定められた目標、タイムライン、予算、および適用される規制要件を順守し、治験の開始から割り当てられたデータベース管理までの臨床試験の運用面を監督します
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: Job-00211678 Posted: 2024-04-10

    [Janssen] Contract & Compliance Services, Site Engagement Analyst

    Open to CRO CRA Candidates
    6 - 9 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are part of a global pharmaceutical company, providing specialized products and services in the medical and health fields. We primarily research, develop, manufacture, and market pharmaceuticals, contributing to the treatment and prevention of disease. Based on innovative medical technologies and scientific approaches, we conduct advanced research and development to bring new treatments and pharmaceuticals to the market. We also develop educational activities and support programs for healthcare professionals and patients, contributing to the improvement of the quality of healthcare. Leveraging our global network, we respond to the needs of diverse regions and markets and promote sustainable medical innovation.
    Responsibilities
    Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversite of a Clinical Research Organization responsible for contract negotiations.
    Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
    Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
    Manage the contract amendment lifecycle.
    Assume responsibility for all aspects of legal document and metrics tracking.
    Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
    Comply with requests from QA and auditors.
    Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
    Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
    Exemplary customer focus with vision to drive solutions
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00241499 Posted: 2024-04-08

    【東京】医薬品の臨床開発におけるデータマネジャー

    データベース構築/運用に関する知識をお持ちの方必見です!
    6 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
    Responsibilities
    当社が主導する臨床試験・臨床研究における国内外データマネジメントCROのオーバーサイト
    効率的なCROオーバーサイト手法の検討
    ウェラブルデバイス、eCOA(electronic Clinical Outcome Assessment)など多様なデータの最適なハンドリングプロセスの策定(使用デバイスの選定への参画含む)
    DDC(Direct Data Capturing)など効率的なデータ収集方法を活用した臨床試験・臨床研究のデータマネジメントプロセス策定
    データエンジニアリング:データ二次利用のためのデータ基盤へのデータ格納/払出し、新規データ種の格納プロセス策定
    Shotaro Tsubaki
    Shotaro Tsubaki
    Medical Device
  • Job number: Job-00210480 Posted: 2024-04-08

    [Osaka or Tokyo] Clinical Team Manager

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

    Company overview
    In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
    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
  • Job number: Job-00210948 Posted: 2024-02-05

    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: Job-00227048 Posted: 2024-01-30

    【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: Job-00233938 Posted: 2024-01-30

    CLT(Clinical Trial Leader)

    モニタリング経験をお持ちの方必見です
    5 - 7 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    同社は医薬品・医療機器開発事業を展開しています。
    Responsibilities
    国内に拠点を持たない海外企業が実施する医薬品開発に関わる臨床試験、製版後臨床試験におけるモニタリング業務をお任せします。
    なお、CTLには、同社メンバーからなるチームのマネジメントに加え、海外顧客やPMとCommunicationを取りながらプロジェクト運営をしていただきます。
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00218265 Posted: 2024-01-29

    【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: Job-00209378 Posted: 2024-01-29

    [Daiichi Sankyo] プロジェクトマネジメント

    CROで開発業務5年以上かつプロジェクトマネジメント業務の経験をお持ちの方必見で
    7 - 10 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
    開発プロジェクトにおけるプロジェクトマネジメントとして、グローバルプロジェクトチームのマネジメント、開発戦略計画、予算、タイムラインおよび課題管理・解決をお任せいたします。
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00233045 Posted: 2024-01-29

    早期臨床開発機能におけるスタディーマネジャー

    世界の患者様に価値の高い新薬を届けることに貢献!
    8 - 11 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development, manufacturing, and sale of pharmaceuticals. We strive to maintain independent management, research, development, production, and sales functions, along with our unique international expansion efforts and the strengthening of our research and development capabilities. Focusing on strategic areas such as "cancer," we are accelerating the creation of promising new drugs, including antibody drugs. We also actively pursue global expansion, aiming to provide high-quality pharmaceuticals and services to patients worldwide.
    Responsibilities
    PoC 取得までの早期ステージにおける、自社創製品の国内外臨床試験の計画および実行の責任者として下記業務をお任せいたします。
    ■業務内容:臨床試験の計画(実施国や実施施設、CROの選定、登録期間の設定など)および実行
    デジタルデバイス、新規システム等を活用した臨床試験の立案および実行
    期間内の症例数集積
    CRO/Vendorオーバーサイト
    Patient Centric活動(患者支援団体からの意見聴取や共働など)
    ※経験や能力に応じて、Study Manager の補佐として採用する可能性があります。

    ■職務の魅力:自社研究所で創製された革新的な新薬候補の価値を早期に証明する臨床開発計画をグローバルチームと協働して立案・実施することにより、世界の患者様に価値の高い新薬を届けることに貢献できます。
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00203664 Posted: 2023-10-20

    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: Job-00207918 Posted: 2023-09-21

    Contracts Manager (グローバルメガファーマプロジェクト)

    臨床試験立ち上げ業務のご経験が活かせます!
    8 - 15 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    In the global CRO market, it is a Japanese subsidiary of a top-level drug development contract entrusted organization.
    Responsibilities
    リーガルの観点から臨床試験の施設契約、機密保持契約の内容が問題ないかレビュー、フィードバックをお任せいたします。
    またCRAやContracts Associate対して、交渉ガイドライン、施設契約に関するトレーニングを実施いただきます。
    臨床試験を実施するCROとの施設契約に関するレビュー、テンプレート内容の交渉
    ガイドライン、日本の相場、適切なSOWに基づく医療機関向け治験費用の分析、および社内承認プロセスにおけるリード
    Global CAチーム、Clinical Operationsチームとの連携および協働し、法的なリスクの評価
    契約における修正条項やその可能性に関する見立て、および分析業務
    契約締結、費用交渉に関するリードタイムの短縮化、効率的なオペレーションの検討
    Patrick Chang
    Patrick Chang
    Pharma
  • Job number: Job-00209417 Posted: 2023-09-21

    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: Job-00227956 Posted: 2023-07-03

    CRA

    CRA
    6 - 8 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.
    Responsibilities
    このポジションでは、国全体(米国、APACなど)で進行中のすべての臨床試験および開発プログラムにプロジェクト サポートを提供いただきます。
    また、スタディリードやグローバルスタディチームのメンバーと密接に連携し、臨床段階における製品開発の計画・実行のあらゆる側面において、開発、積極的な管理、
    確実なデリバリー、また前臨床から商業化への製品ライフサイクルを通じて他の機能領域をサポートいただきます。
    <詳細業務内容>開発のさまざまな段階で世界中で実施されている1~3件の臨床試験をサポートする場合があります。
    質の高い臨床試験がプロトコールに従って適時に実施され、SOP、ICH/GCP/規制ガイドライン、会社の目標、確立された研究予算に準拠した方法でチームを支援
    主な研究活動と必要性に関する情報を作成、維持、および追跡
    臨床試験を実施するためのさまざまなシステムへのアクセスを作成および維持
    必要に応じ、米国臨床レジストリおよびその他の関連するローカル レジストリを作成および維持
    進行中の臨床文書や活動をサポート
    必要に応じ、適格性審査プロセス、よくある質問、データ審査、調整活動、プロトコル逸脱審査など、その他の主要な臨床活動を支援
    治験実施施設との機密保持契約の法的な執行を調整
    資金管理活動において、臨床業務の主導者を支援し、予算/予測から実際の支出を確認
    サイト固有の規制パケットを取得、確認、追跡し、臨床オペレーションリーダーからの要求に応じて発送を開始
    TMF計画およびファイル試験構造に従い、試験マスターファイルの設定と維持を支援
    TMFのQCレビューを管理し、試験実施全体を通じて部門間でQC活動を調整
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
  • Job number: Job-00203431 Posted: 2023-07-03

    Senior Clinical PMS Manager

    In charge of all clinical PMS
    12 - 17 million yen Tokyo Pharmaceutical Clinical Development

    Company overview
    We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.
    Responsibilities
    Accountable for day to day activities of all aspects of the operational management of local post-marketing studies (PMCT and PMS), including study timelines, resources, allocation and management of product (re-) supply, problem identification and resolution, status reports and budget to ensure timely delivery of completed study reports to the project teams
    Accountable for the oversight of investigator-initiated studies granted by the company, including the support of the set-up and operational assessment of investigator-sponsor, tracking performance and payments according approved plan, managing product supply, if applicable, coordinating internal review of final report
    Manage independent consultants including CROs, clinicians, independent CRAs, or statisticians when required by the project including selection, coordination of project specific training, and payment
    Develop and monitor study budget and timelines
    Monitor work to ensure quality
    Ensures that trial status is tracked and entered into the respective Clinical Trial Management System
    Contribute to the planning and set-up of a study and provide planning parameters
    Overseeing external providers, Act as an interface between Global Clinical Operations and local organizations (Global Operations)
    Martin Tsvetkov
    Martin Tsvetkov
    Pharma
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