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R＆D, Clinical Research Associate（CRA）/Site Manager, Global Clinical Operation Japan （Tokyo）
年収：800万 ～ 1000万
採用企業案件
ヤンセンファーマ株式会社
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- 会社規模501-5000人
- 医薬品メーカー
| 部署・役職名 | R＆D, Clinical Research Associate（CRA）/Site Manager, Global Clinical Operation Japan （Tokyo） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
[概要] 治験の実施に関わる施設選定～データベースロック/治験終了までのモニタリング業務 [具体的な業務例] ・治験契約締結交渉・初回IRB申請手続き ・施設セットアップ、医療関係者トレーニングの実施 ・症例登録促進活動の実施、GCP・SOPに基づくモニタリング ・治験の質的管理、原資料等の直接閲覧/症例報告書のSDV実施 ・施設における治験費用の管理 ・その他、社内のImprovement activity / Task force teamへの参加 Position Summary: A Site Manager I in Early Development & Clinical Pharmacology (ED&CP) serves as a primary contact point between the sponsor and the investigational site (both commercial and hospital) for the conduct of early development and/or clinical pharmacology studies. A Site Manager I is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), Health Care Compliance requirements (HCC), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site assessments, pre-trial assessments, site selection, site initiation, subject recruitment and retention, monitoring and close-out. Partners with the Clinical Trial Assistant (CTA), Trial Manager (TM) and Global Trial Leader (GTL) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager I may contribute to process improvement and training. Principal Responsibilities: 1. Participates in site assessments, conducts pre-trial site assessment visits and/or participates to study feasibility assessments, providing recommendation from local area about site/investigator selection in collaboration with the trial team 2. Acts as primary contact for assigned sites for specific ED&CP trials and works closely with TM and trial central team regarding study progress and issue resolution. 3. Attends/participates in investigator meetings as needed. 4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural documents and policies. 5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at sites and sponsor level. 6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target. 7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct. 8. In collaboration with Site Investigational Product Specialist (SIPS) and Pharmacy Investigational Product Specialist (PIPS), ensures that clinical drug supplies are appropriately handled, administered and stored. Ensure strict adherence to investigational product preparation and administration guidelines. Ensures clinical drug supplies are appropriately inventoried, accounted and returned as applicable including maintenance of accurate and complete documentation. 9. Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with TM when needed. 10. Ensures accuracy, validity and completeness of data collected at trial sites. Ensure appropriate measures are in place for maintenance of the blind when applicable 11. Ensures that all Adverse Events (AEs)/Serious Adverse events (SAEs)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents. 12. Maintains complete, accurate and timely data and essential documents in systems utilized for trial management. 13. Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented. 14. Reviews investigator site file for completeness and ensures archiving retention requirements, including storage in a secure area at all times. 15. Collaborates with TM for documenting and communicating site/study progress and issues to trial central team. 16. Attends regularly scheduled team meetings and trainings. 17. Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops sufficient therapeutic area and early development knowledge to support roles and responsibilities. Works across therapeutic areas dependent upon ED&CP business needs. 18. Works closely with TM to ensure Corrective Action Preventive Action (CAPA) is completed for QA site audits or Inspection and for quality issues identified at the site during routine monitoring and other visit types, e.g., On Site Quality Monitoring visit (OSQMV). 19. Prepares trial sites for close out, conduct final close out visit. 20. May review and manage site specific informed consent forms in accordance with GCO SOPs, procedural documents and applicable regulations. 21. May participate in the HA and IEC/IRB submission and notification processes as required/appropriate. 22. Tracks costs at site level and ensure payments are made, if applicable or collaborates with C&G in charge of site payments. 23. Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators, other site staff and key contacts in Early Development and/or Clinical Pharmacology. 24. Coordinates site level lessons learned activities. 25. May contribute to process improvement and training Principal Relationships: Primary Reporting Structure: Reports to Functional Manager (FM). Primary interfaces: FM, CTAs, TMs, SMs. SIPS, PIPS, GTLs, Study Responsible Physicians (SRPs), Quality and Compliance Manager/Specialist, Local Safety Officer Other Internal Interfaces: C&Gs, GPLs, TA representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch Quality and Compliance (BRQC), ED&CP Head/US ED&CP head, ED&CP Business Operations & Quality Leader and others as required External Interfaces: Investigational Site Staff and others as required |
| 応募資格 |
【必須（MUST）】 ・治験実務あるいはモニタリング業務経験：3年以上。・担当領域：イムノロジー ・単独で治験の施設を担当し、GCPに従ったモニタリング業務の遂行 ・Phase2もしくはPhase3の開発実務経験 (医師主導治験や臨床研究は含まない。抗がん剤の場合はPhase1も含む) ・Global Process（FDAやEMAのRequirement、ICH GCPに則ったプロセス≒国内および海外での申請を目的とした国際共同治験）に基づく治験実務担当経験 ・治験実務/モニタリング業務において、大学病院・国公立病院を担当した経験 ・単独でSite Initiation phase（合意～Site open）を2つの異なる試験もしくは5施設以上で経験していること ・Issue managementに関する基礎知識を有し、それに基づく実務経験 ＜必要とする能力・スキル＞ ・英語での読み書きができる（目安としてTOEIC 650点以上） ・パソコン等：Word、Excel、PowerPoint、EDCやCTMSなどのシステムが使える ・日本国内の医療機関訪問を目的とした出張が可能な方（飛行機搭乗を伴う出張有） ＜学歴＞ ・医学、薬学、生物学系大学 学部卒業以上 【歓迎（WANT）】 ・外資系企業でのCRA担当、あるいはGlobal Studyへの参画経験【求める人物像】 自己認識・分析ができている人。 他者からの助言やFeedbackを素直に吸収できる人。 円滑な業務遂行のため、社内外の関係者と良好な関係を構築する意識とコミュニケーション力を持っている人。 自身の意見をもち、自ら進んで発信できる、かつ建設的な対話力を有する人 業務の成果達成に対して責任をもち、常に前向きに取り組める人。 環境や業務量の変化、困難な問題や状況、ストレスといった要素に直面しても、うまく適応し柔軟に対応できる人（レジリエンスが高い人）。 担当業務のみならず、プロジェクトチームや組織に対して積極的に貢献すべくリーダーシップを発揮できる人。 |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2026/01/19 |
| 求人番号 | 5098212 |
採用企業情報
- ヤンセンファーマ株式会社
-
- 会社規模501-5000人
- 医薬品メーカー
-
会社概要
私たちヤンセンファーマは、世界最大級のトータル・ヘルスケア・カンパニー、
ジョンソン・エンド・ジョンソン（J＆J）グループの製薬会社として、いまだ
満たされていない医療ニーズに迅速に応え、最先端の医薬品を一刻も早く患者
さんの手元に届けることができるよう取り組んでいます。
私たちは、世界57ケ国200社以上に及ぶJ＆Jグループを貫く経営理念「我が信条
（Our Credo）」を志とし、さらに、46年間に84品目もの新薬を開発したヤンセ
ン・ファーマスーティカ社の創業者、ポール・ヤンセン博士の妥協なき開発精
神を継承し、J＆Jグループの優れた新薬の導入はもちろん、医療現場への適切
かつ最新の医療情報の提供、さらには、患者さんのＱＯＬ（クオリティ・オブ・
ライフ）の向上を目指した支援活動などをおこなっています。
転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です