Jobs list of Pharmaceutical & Clinical Development
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Job number: JN -072024-5073 Posted: 2025-10-21
Clinical Trial Manager
CTM8 - 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
Industrial & Life Science -
Job number: JN -102025-194715 Posted: 2025-10-15
臨床開発リード｜Clinical Development Lead
臨床開発戦略の立案と実行をリード10 - 17 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- We are a company engaged in the manufacturing, sales, import, and export of pharmaceuticals and quasi-drugs. Guided by our philosophy of "enhancing people\'s health and contributing to a richer society," we focus on the introduction and development of innovative new drugs, particularly anti-allergy medications. As medical technology advances with developments such as genomic drug discovery and personalized medicine, we are committed to going beyond the fundamental role of the pharmaceutical industry to support a comfortable life for people, especially in an aging society. Our business includes the import, export, manufacturing, and sales of pharmaceuticals and quasi-drugs, chemicals (such as methylamine and plasticizers), and films (such as label films and sterilization paper). We continually strive to provide truly useful pharmaceuticals to many people, always challenging and progressing forward.
- Responsibilities
ベルギーに本社を置く、神経学・免疫学に特化したグローバルバイオファーマにて
【クリニカル・ディベロップメント・リード】
を募集しています。
日本法人は37年前に設立され、抗てんかん薬、関節リウマチ治療薬および乾癬治療薬を中心に医薬品事業を展開しています。
従来の治療で十分な改善が得られなかった患者さんに、新たな治療の選択肢を提供することを目指しています。
また、同社は単に業務をこなすのではなく、価値を創造すること
を大切にしています。
挑戦を恐れず、協力し合い、革新を追求しながら、患者さんのために成果を出すことを目指しています。
誰もが尊重され、受け入れられ、最善を尽くせる平等な機会があり、思いやりと支援に満ちた文化が根付いています。
同社で働くことで、自分自身の成長を実感し、自由にキャリアを築き、可能性を最大限
に引き出すことができます。
◤患者さんのためにあなたの力を発揮していただけませんか？◢
―――――ポジションについて
―――――
東京に拠点を置く臨床開発チームの一員として、担当製品の日本における臨床開発戦略の立案と実行をリードしていただきます。
社内外のステークホルダーと連携しながら、規制当局対応、申請書類作成、外部専門家とのネットワーク構築などを通じて、製品の成功に貢献する役割です。
■業務内容：日本における臨床開発計画の立案と実行
規制当局との対応および申請書類の作成支援
外部専門家とのネットワーク構築と関係維持
臨床試験の設計、実施、評価、報告の監督
社内外ステークホルダーへの戦略説明と調整
薬事申請、承認、上市に向けた臨床面での貢献
■チーム
臨床開発、メディカルアフェアーズ、薬事、ファーマコビジランス、マーケティングなどの社内関係者と密に連携しながら、日本の臨床開発戦略を推進するチームで働くことになります。グローバルアセットチームや関連部門とも協働し、日本の視点を反映した開発計画を策定・実行します。
━━━━━━━━━━━━━━━#spotlightjob4
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-143283 Posted: 2025-10-09
[Osaka & Tokyo] Clinical Research Associate (CRA) in Operation
Rewarding Career, Global Development9 - 14 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
- 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
Industrial & Life Science -
Job number: JN -072024-6846 Posted: 2025-10-09
Inexperienced CRA
Inexperienced4.5 - 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
Industrial & Life Science -
Job number: JN -072024-143554 Posted: 2025-10-09
Clinical Project Manager / Clinical Leader
Global Trail and high salary8.5 - 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
Industrial & Life Science -
Job number: JN -092025-194128 Posted: 2025-09-19
開発企画推進部（統計解析職/リーダークラス )
製薬企業・CROで統計解析担当者として、3年以上の業務経験が活かせます。6.7 - 8.2 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is selling, importing and exporting pharmaceuticals and other products.
- Responsibilities
- 治験計画時：治験相談、症例数設計、プロトコル作成サポート、統計解析計画書作成
治験実施中：解析帳票/CDISCデータ作成（業務委託先のコントロール）
治験終了時：解析報告書作成、CSR/CTD作成サポート
承認申請時：CDISCデータ提出、照会事項対応、適合性書面調査対応
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-191455 Posted: 2025-09-18
【東京】クリニカルリサーチマネージャー（オンコロジー経験）
オンコロジー領域におけるCRM経験者必見です!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
- 米国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っていただきます。
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
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-13688 Posted: 2025-09-17
【東京】GCP監査担当者(責任者候補）
英語での文書作成及びレビュー経験を有する方必見です。5 - 9 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
- CRO業務における品質管理の一環としての GxP監査業務（内部監査、ベンダー監査）及び関連する業務全般を実施いただきます。
GCP等の臨床試験の業務委託先の選定及び再確認を目的とした国内外のVendorアセスメント監査の実施
受託Projectに対する内部監査・受託監査の実施
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-33887 Posted: 2025-09-01
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 CRO5 - 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
Industrial & Life Science -
Job number: JN -072024-143282 Posted: 2025-08-29
[Osaka or Tokyo] Clinical Team Manager
Strong Global Foot Print and High Salary9 - 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
Industrial & Life Science -
Job number: JN -082025-192642 Posted: 2025-08-18
プロジェクトマネジメント業務
製薬企業又はCROでPMまたはモニタリングリーダーの経験のある方必見です7 - 10 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our Client utilizes imaging technologies such as PET, CT, and MRI to contribute to improving the development efficiency and success rates of pharmaceutical companies.
- Responsibilities
- クライアント要求事項の整理と対応（クライアントとのメイン窓口）
成果物等をクライアントに提供する計画提示
関連部署におけるチームビルディング
プロジェクトのRiskとIssue管理
担当プロジェクトにおける業務範囲の明確化・スケジュール管理と継続した現状分析
社内外におけるStakeholderの特定
プロジェクトの影響範囲と遭遇する諸問題の次善策を検討等
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-191966 Posted: 2025-07-30
グローバルプロジェクトマネジメント業務
新薬の開発経験をお持ちの方必見です7.66 - 12.97 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
- 開発プロジェクトのプロジェクトマネジメント業務下記の活動を通じてプロジェクトを計画通り推進する。開発プロジェクトチームの主要なインテグレーターとして、プロジェクトマネジメントツールおよびテクニックを活用し、チームビルディングとチームのモチベーションを向上させるリーダーシップスキルを発揮する。
さまざまな開発相にわたる開発プロジェクトを組織の目標とスケジュールに沿うように管理する。
包括的なプロジェクト予算とリソースを作成し、モニタリングする
チームと協力して統合されたプロジェクトタイムラインを作成し、進捗をモニタリングし、必要に応じて変更を施す
潜在的なリスクを事前に特定し、リスク緩和策を策定、実行する。
部門、チーム、地域を越えて効果的にコミュニケーションを取り、プロジェクトを推進する。主要な文書の管理、透明性の確保、教訓やベストプラクティスの共有により、チームのパフォーマンスを最適化し、組織内のプロセス改善を促進する。
組織の要求事項に対応し、ガバナンス会議、承認プロセス、部門間の連携などを含め、プロジェクトを円滑に進め、管理する。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-144139 Posted: 2025-07-29
[Janssen] Contract & Compliance Services, Site Engagement Analyst
Open to CRO CRA Candidates6 - 9 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- Our client is a leading global pharmaceutical firm with a presence in about 150 countries and a workforce of around 40,000 employees. The company is dedicated to advancing healthcare through innovative treatments across various therapeutic areas.
In Japan, the firm employs over 2,500 professionals focused on delivering solutions tailored to the specific needs of the local population. By integrating global advancements with local insights, the company collaborates closely with healthcare providers to ensure effective and accessible therapies.
Committed to sustainability and corporate responsibility, the firm strives to improve patient outcomes and enhance the quality of life. Its efforts make significant contributions to both the local and global healthcare landscape. - 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
Industrial & Life Science -
Job number: JN -072025-191365 Posted: 2025-07-18
臨床開発やプロジェクトマネジメント
バイオ医薬品、細胞製品、再生医療等製品での臨床開発またはプロジェクトマネジメントのご経験をお持ちの方必見です6 - 12.99 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- 同社は不妊治療等の研究開発を行うバイオベンチャーです。
- Responsibilities
- 【採用目的】細胞製品上市のために開発をリードできる人材の確保のための募集です。本ポジションでは、細胞製品の臨床開発やプロジェクトマネジメント業務を担当していただきます。【採用背景及び業務内容】同社はiPS 細胞を利用した生殖補助医療の開発に取り組む会社です。現在臨床研究にフェーズが移行しており、今後はCDMO含め外部機関や規制当局とのやりとりが増加することが想定されます。そこで同社としては現在、同社の細胞製品の開発を加速し、国内外の規制当局への申請を円滑に進めるため、臨床開発およびプロジェクトマネジメントを担う新たなメンバーを募集します。
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072025-191005 Posted: 2025-07-10
クリニカルリサーチマネージャー
CRM（Clinical Research Manager）やStudy Manager等のご経験が活かせます。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
- 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
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-7373 Posted: 2025-07-09
Clinical Development Sr.Mgr
Clinical Development Sr.Mgr10 - 16 million yen Tokyo Pharmaceutical Clinical Development
- Company overview
- 新薬の製品化を目指した研究開発、および販売を手掛けています。
- Responsibilities
- 国内外の導入元または共同開発先スタッフとの協議、交渉およびコミュニケーション
開発プロジェクトのプロジェクトマネジメント業務
プロジェクト推進のためのインフラストラクチャー整備、業務効率化提案・実装
臨床開発開始から製造販売承認取得に至るまでの開発戦略・開発計画の策定
治験相談や適合性調査等を含む規制当局との面談等の準備およびリード
治験実施計画書等の策定
治験実施施設の選定、契約から治験終了に至るまでのGCP に基づく実務および管理
CRO およびベンダーの選定、交渉、契約、CRA を含む各スタッ フの支援・管理
治験総括報告書の作成
製造販売承認申請資料の作成
Patrick Chang
Industrial & Life Science -
Job number: JN -072024-137825 Posted: 2025-07-08
Clinical Trial Leader
Managing all clinical activities12 - 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
- Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
Accountable for oversight of CROs in the execution of Phase I – III global clinical trial(s).
Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
Accountable for the successful preparation and presentation of operational content at key governance discussions
Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team
Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
Accountable for partnering with CRO in audit responses and addressing quality issues.
Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
Ensures strong inspection readiness application for all assigned clinical trials.
Manages a small project or project stream with tasks of low to moderate complexity within a larger project. Leads a small project team with members typically from direct working environment and a straightforward project structure. Coordinates stakeholders from own area or even closely related areas or is partially or even fully responsible for the project’s management within small to medium sized projects. Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
Accountable for projects within a clearly defined scope and milestones. Receives moderate to low level guidance and direction within broad guidelines.
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-143741 Posted: 2025-07-08
Senior Manager Clinical Research
Global position12 - 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
Industrial & Life Science -
Job number: JN -062025-190230 Posted: 2025-06-25
Senior Clinical Trial Manager
臨床開発業界におけるPMやCTMのご経験をお持ちの方必見です10 - 14 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
- 同社のFSP部門（Functional Service Provider）における外部就労案件にてClinical Trial Lead（同社タイトルSenior Clinical Trial Manager想定）として下記ご担当いただきます。臨床試験（治験）の実施と承認申請を担う実務責任者として、海外チームと連携してグローバル開発戦略を作成し、社外オピニオンリーダー、研究部門、製薬技術部門、グローバルマーケティング部門等と連携しながら臨床開発計画の立案、臨床試験計画立案・実施、各国当局に対する相談・承認申請の中心的役割を担っていただきます。※レポート：JapanのClinical Operations Lead
Martin Tsvetkov
Industrial & Life Science -
Job number: JN -072024-138039 Posted: 2025-06-16
CRA/Senior CRA
Both RA and Clinical work8 - 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
Industrial & Life Science