Jobs list of Pharmaceutical & Clinical Development

【東京】臨床開発スタディマネジメント◇ML・SM経験歓迎／在宅可◎

未経験でも安心してスキル習得や能力/キャリア開発をいただけるような体制が整っています。

5.5 - 9.5 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Japanese CRO Company that deal with Oncology.
Responsibilities: 【スタディマネジメント担当者】
■業務内容：臨床試験のスタディマネジメント担当者（CA/SL）として、臨床試験の運営・管理業務全般（CROマネジメント・予算/進捗管理など）をご担当いただきます。スタディマネジメント未経験でご入社の場合には、まずはCA業務からご担当いただき、将来的にはスタディマネジメント業務の責任者「Study Leader」をお任せしたいと考えております。

■業務詳細：臨床試験の運営・管理業務全般（予算管理や進捗管理、方針決定、治験届出や承認申請対応など）
国内外のCROを含むベンダーの管理・監督
ロシュ社やその傘下にあるジェネンテック社を含む海外担当者とのコミュニケーション/ディスカッション
医療機関における治験担当者との交渉
中外製薬の臨床開発における運営・プロセスの改善提案（新たな企画の検討、DX推進）など

■組織構成：オンコロジー開発部/スペシャリティ開発部
約94名（8グループ編成）※2025年5月時点

■研修制度：入社後6か月間のメンター制度や、充実した研修制度、年に1回の学会参加費用の負担や年代別のキャリア研修の実施など、未経験でも安心してスキル習得や能力/キャリア開発をいただけるような体制が整っています。

Project Manager

PMやCTMとしての業務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 Project Manager（同社タイトルProject Manager想定）として下記ご担当いただきます。仕事詳細:
プロジェクト全体の計画を策定し、CROとの効果的なコミュニケーションを実施また進捗管理を行う
プロジェクトのスケジュール、リソース、予算の管理と調整を行い、問題発生時には適切な対策を講じる。
社内の他部署と連携し、情報共有・意思決定を円滑に進める。
競合状況や市場動向を把握し、KOLや治験施設とのコミュニケーションを図る。
CRO（臨床試験受託機関）や他の外部パートナーとの調整・交渉を担当し、契約内容や進捗状況を監督する。
プロジェクトリスクの評価と管理を行い、リスク軽減策の立案および実施をリードする。
プロジェクトに関連する規制当局対応や内部監査、品質保証活動をサポートする。
プロジェクトに関わるドキュメントの管理、レビューおよび報告書作成を行う。
プロジェクト終了後の振り返りや教訓の共有を推進し、業務改善に貢献する。
データモニタリング委員会や安全性監視委員会の会議運営のサポートを行う。
出張が発生することがあります（宿泊を伴う場合あり）

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

【東京】臨床開発スタディマネジメント

CRA・SM経験者歓迎です!

5 - 7.7 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Japanese CRO Company that deal with Oncology.
Responsibilities: 臨床試験のスタディマネジメント担当者（CA）として、臨床試験の運営・管理業務全般（CROマネジメント・予算/進捗管理など）をご担当いただきます。
業務未経験でご入社の場合には、まずはCA業務からご担当いただき、将来的にはスタディマネジメント業務の責任者「Study Leader」をお任せしたいと考えております。
臨床試験の運営・管理業務全般（予算管理や進捗管理、方針決定、治験届出や承認申請対応など）
国内外のCROを含むベンダーの管理・監督
海外担当者とのコミュニケーション/ディスカッション
医療機関における治験担当者との交渉
同社の臨床開発における運営・プロセスの改善提案（新たな企画の検討、DX推進）など

[Janssen] Contract & Compliance Services, Site Engagement Analyst

Open to CRO CRA Candidates

6 - 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

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

Clinical Trial Leader

Managing all clinical activities

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: 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.

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

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

生物統計業務

承認申請業務経験をお持ちの方必見です。

7.54 - 12.84 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: 各開発プロジェクト（国内開発およびグローバル開発）における下記業務生物統計学的観点からの臨床開発計画および臨床試験計画の立案
臨床試験における統計解析計画の立案および統計解析結果の解釈
承認申請および照会事項対応における統計解析計画の立案および統計解析結果の解釈
照会事項対応、主要、副次評価項目等の解析プログラミング（必要に応じて）
業務を委託する場合、ベンダーの管理、監督

臨床開発（シニアマネジャー）

Project Lead／Project Managementの経験がある方必見です。

11 - 14 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a global pharmaceutical firm with expertise in researching, manufacturing, and selling regenerative medicine. It stands as a trailblazer in the realm of regenerative medicine, having pioneered a new category of medical solutions. While its core focus is on brain injuries/diseases and central nervous systems, it\'s also actively advancing in the sphere of cancer and neurological disorder treatments.
Responsibilities: 臨床試験の実施に際し、CRO・ベンダー・試験実施施設を監督し、リスクを特定して運用上の問題を解決することで試験の進捗をモニタリング
合意されたスケジュール・予算、および社内標準の品質で試験実施施設の管理とモニタリングに関する全てのアクティビティを主導し管理
施設選定／被験者募集戦略の立案及び実施
問題をタイムリーに解決することにより臨床試験データの質を確保
CROが試験実施施設の管理を実行するためのリスク軽減プランとコンティンジェンシープランの作成と管理
信頼性保証部門と協力して外部/内部監査に関連する活動をリードし、割り当てられたプロジェクトに関して規制当局の査察対応に貢献
全ての試験関連文書が最終保管されていること、そしてTMFが完成していることを保証
試験実施計画書、同意説明文書作成への関与、日本語と英語間の翻訳を保証
試験の管理に関する課題のエスカレーションを行なうと共に、課題解決に貢献
臨床開発計画立案及び機構相談資料、試験総括報告書、CTD、照会事項回答作成に関与

臨床試験プロジェクト

CRA経験かつClinical Trial Manager (CTM)の経験をお持ちの方必見です

8.5 - 11 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a global pharmaceutical firm with expertise in researching, manufacturing, and selling regenerative medicine. It stands as a trailblazer in the realm of regenerative medicine, having pioneered a new category of medical solutions. While its core focus is on brain injuries/diseases and central nervous systems, it\'s also actively advancing in the sphere of cancer and neurological disorder treatments.
Responsibilities: 臨床試験の実施に際し、CRO・ベンダー・試験実施施設を監督し、リスクを特定して運用上の問題を解決することで試験の進捗をモニタリング
合意されたスケジュール・予算、および社内標準の品質で試験実施施設の管理とモニタリングに関する全てのアクティビティを主導し管理
施設選定／被験者募集戦略の立案及び実施
問題をタイムリーに解決することにより臨床試験データの質を確保
CROが試験実施施設の管理を実行するためのリスク軽減プランとコンティンジェンシープランの作成と管理
信頼性保証部門と協力して外部/内部監査に関連する活動をリードし、割り当てられたプロジェクトに関して規制当局の査察対応に貢献
全ての試験関連文書が最終保管されていること、そしてTMFが完成していることを保証
試験実施計画書、同意説明文書作成への関与、日本語と英語間の翻訳を保証
試験の管理に関する課題のエスカレーションを行なうと共に、課題解決に貢献
臨床開発計画立案及び機構相談資料、試験総括報告書、CTD、照会事項回答作成に関与

【東京】臨床開発プロダクトリーダー

臨床開発のモニタリング経験者必見です!

7 - 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: 開発部門では国内外で実施する臨床試験の企画・管理・モニタリングなど様々な業務を行っており，チームで企画からモニタリング業務まで担当します。
分業制をとっていないのが特徴で、PLはプロダクトチェアーと連携し、プロダクトの開発方針を基に試験実施計画書を立案・作成し、試験実施責任者として試験推進をリードしていただきます。
＜具体的に＞治験実施計画書の立案・作成、治験薬概要書（臨床）の作成と改訂
治験の実施責任者として、臨床チーム（CTL,モニター）およびCROを統括管理
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
CTL、モニターの指導、教育
総括報告書の作成、国内申請資料（臨床）の作成

統計解析者

関連ソフトウェア言語の実務知識をお持ちの方必見です

6 - 11.5 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Our client is a leading global pharmaceutical company committed to enhancing health and quality of life. With a significant presence in Japan, the firm operates from its Tokyo branch with over 1,500 dedicated employees.

Globally, the company employs over 58,000 people and has a footprint in more than 130 countries. The focus is on research and development in key therapeutic areas, including respiratory, cardiovascular, and oncology, driving innovation and excellence across its extensive pipeline of therapies.
Responsibilities: フェーズI-IVの臨床試験やBIの経験に基づくプロジェクトを含む複雑な研究/プロジェクトの設計、変換、分析、および報告を担当します。また、特定のユースケースやプロジェクト/資産に関連する臨床薬剤ライフサイクルプロセスからの他のデータ（レジストリや実世界のデータベースなど）の設計、変換、分析、および報告を担当します。

[Tokyo] Experienced CRA (including Sr./Pri.)

Global Pipeline with Work Life Balance

4 - 10 million yen Tokyo Pharmaceutical Clinical Development

Company overview: Leading global CRO company
We provide drug discovery, development, lifecycle management and laboratory services.We are a company that provides services related to drug development. We are responsible for the collection and analysis of clinical trial data for pharmaceutical products, support for regulatory filings, and quality control. Our team of experts provides tailored solutions to ensure the safety and efficacy of our clients\' needs. We are focused on providing high quality services in compliance with strict regulations. We provide professional support with our experience and knowledge to help our clients succeed in drug development.
Responsibilities: Work to confirm (monitor) whether clinical trials are conducted in accordance with relevant laws and regulations (GCP) and implementation plans (protocols) at appropriate medical institutions under consignment from clients, and whether the human rights and safety of subjects are protected is. Selection of medical institutions and doctors in charge of conducting clinical trials
Confirmation of clinical trial schedule and contract details, and implementation of briefing sessions for medical institution staff
Clinical trial progress management: Progress management of the number of cases, collection / inspection of case report reports, collation of case report reports with materials
Delivery of investigational drug, confirmation of supply management status, collection
Preparation of monitoring report
Clinical trial completion procedure, confirmation work

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

Rewarding Career, Global Development

9 - 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

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: 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: 【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

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

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

プロジェクトマネージャー（PM）日本発のグローバルCRO

製薬業界もしくはCRO業界にて少なくとも8年以上の臨床開発経験が活かせます。

9.4 - 14.5 million yen Tokyo Pharmaceutical Clinical Development

Company overview: We specialize in supporting new drug development. Our fundamental philosophy is to consistently provide professional quality in all aspects of pharmaceutical development and to pursue the happiness of our stakeholders, including pharmaceutical companies, medical institutions, patients, shareholders, and employees. Founded by nine members who previously worked on new drug development at a major domestic pharmaceutical company, we leverage our extensive experience in developing drugs such as immunosuppressants to support the entire new drug development process. Currently, in response to the pharmaceutical industry\'s increasing reliance on outsourcing, we have established a system centered around highly knowledgeable and capable CRAs to provide fast and accurate data. Additionally, we have built a global support system for new drug development, using our Japan office as a hub to facilitate international joint clinical trials across Asia, Europe, and the United States. We also place a strong emphasis on employee education, continually enhancing our training systems to ensure ongoing skill development.
Responsibilities: 顧客重視のリーダーシップを持ち、PhaseⅠからPhaseⅣまで複数の臨床研究試験を管理する。
グローバルチームと連携し、日本やアジアプロジェクトチームおよび他部門との協業，調整，進捗管理を行う。
プロジェクトのリソースを調整し、契約や予算を遵守するよう管理する。必要に応じてChange Orderを顧客へ提案し、締結するよう調整する。
顧客、グローバルチームやベンダーの要望を考慮し、目標達成するようアクションおよびタイムラインを計画し、管理する。
BidとProposalなど事業開発活動をサポートする。
リスクマネジメントベースで、複数のサイト/国で指摘されている潜在的な傾向に関する最新情報を提供し、上級管理者および顧客とともに防止策について議論する。
PMのラインマネジメントを行い、PMをサポートし指導する

Jobs list of Pharmaceutical & Clinical Development

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