[ 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

•治験実務あるいはモニタリング業務経験: 3 年以上。医療機関での看護師•薬剤師• CRC 経験と併せて 3 年以上でも可

•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

•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)

•特になし

•医学, 薬学, 生物学系大学学部卒業以上

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。

好まれる職歴等

外資系企業での CRA 担当, あるいは Global Study への参画経験

勤務地: 大阪

応募書類

本人用意の履歴書•職務経歴書(日本語)(職務経歴書(英文)提出可能でしたら添付ください。)

職務経歴書に以下の内容を記載ください。

•ご自身が最も Value を発揮できる Therapeutic ( Disease ) area もしくは疾患名

•ご自身が経験した最も対応に苦慮した Issue 及びその対応策の紹介

•医師主導治験や臨床研究を除く一般的な臨床試験において, 以下の期間ごとに

同時並行で担当した最大の施設数, 対象疾患(領域), 試験の Phase, その状態が継続した期間

Site initiation phase (合意~ Site open (組み入れ可能))

Conduct(Enrollment) phase ( FPI ~ LPI )

Ex.) Site initiation phase: 4 施設, 多発性骨髄腫, Ph1, 6 ヶ月

#GIFTS

ジョンソン•エンド•ジョンソンでは, 従業員とその周りの方々, そして私たちの製品やサービスをお届けする顧客の感染予防, 地域社会における感染拡大防止のため, またヘルスケアカンパニーとしての当社事業の安定的な 継続のために, 入社予定者の方には, 入社前もしくは入社後速やかに COVID-19 ワクチン接種を完了していただくことを強く推奨しています(ワクチン接種ができない既往歴がある方等は除きます)。

Education and Experience Requirements:

A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.

A minimum of 1 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility. Experience in monitoring ED& CP studies is preferred.

Specific therapeutic area experience/knowledge may be required.

Good working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.

Good IT skills in appropriate software and company systems.

Willingness to travel with occasional/regular overnight stay away from home depending on the region.

Proficient in speaking and writing the country language and English. Good written and oral communication skills.

Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment.

Ability to work on multiple trials in parallel in different disease areas

#GIFTS

Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).