Senior Manager, Clinical Trial Manager

extra[not]ordinary® な未来を共に築くことを使命とし、革新的な抗体製品の開発や人々を感動させる抗体医薬品で、がんやその他の深刻な病に苦しむ患者さんの生活を根本的に変え、治療の未来を切り拓いています。

Overview

The Sr. Manager, Japan Clinical Trial Manager (JCTM) is accountable for delivery of Japan and / or selected deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., eCRF, IRT, eRT], support site activation and recruitment, support data review / cleaning activities, support PI / ICF development). Scope of responsibilities depending on number of patients / sites / size of trial.

The Sr. Manager, JCTM is accountable for the end-to-end delivery of a single clinical trial from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Team (CTT) to deliver clinical trials including managing the trial budget if assigned to a trial as Global Clinical Trial Manager (GCTM).

As Sr. Manager, JCTM, the employee represents Japan Development Operations (JDO) in one or more Japan Compound Teams (J-CoT) and contributes to the compound development strategy in Japan.

Responsibilities / tasks as CTM

Trial Planning and Oversight

• Set target timeline, target number of patients, and required number of sites in Japan together with GCTM, JCoT members, CRO, and other related stakeholders
• Review Task Orders with CROs for Japan
• Involve in optimizing site costs in Japan as needed
• Develop operational plans, manuals and charters for the trial
• Review protocol and protocol amendments
• Coordinate development of Trial Oversight Plan
• Review Investigator's Brochure (IB) from DevOps perspective
• Review Clinical Trial Application (CTA) submission package
• Review Regulatory Green Light (RGL) packages in accordance with QDOC-
• Review Development Safety Update Report (DSUR)
• Develop Global Master ICF
• Follow up on Trial Oversight identified findings during Oversight until closure

Site Selection and Management

stakeholders

Vendor Management and Oversight

of the partnership dedicated model which is managed via Oversight Manager)

Trial Execution and Monitoring

information and collection and providing of relevant trial documents)

on tracking and reconciliation of trial related items such as scans, blood samples etc.

Responsibilities / tasks as GCTM

Trial Leadership and Management :

Budget and Planning :

outline though CSR (Gap : GCTM / CPL need a planner, e.g., MS Project, to show end to

end project timelines and to build trust in organization)

Risk management :

Japan specific responsibilities / tasks

Drug Development in Japan :

o Work with JCTM to ensure each study progress and milestone achievement in

Japan

o Ensure that departmental input / knowledge that could impact the setup and

conduct of trials is proactively considered and discussed upon operationalization of the trials

o Proactively provide input on the development strategy of compound as a

representative of JDO

The Employee shall also render such other related services and duties as may be assigned from time to time by supervisor.

LI-DNP

25年間、情熱的で革新的、そして協力的なチームが、次世代抗体技術プラットフォームを開発し、トランスレーショナルサイエンス、定量科学、データサイエンスを活用することで、独自のパイプラインを確立してきました。このパイプラインには、二重特異性T細胞エンゲージャー（bispecific T-cell engagers）、抗体薬物複合体（ADC）、次世代免疫チェックポイントモジュレーター、エフェクター機能強化抗体などが含まれています。

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