Clinical Trial Leader

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
Clinical Trial Leader

Job Purpose
To plan, prepare and execute Translational Clinical Oncology (TCO) trials in Japan by leading Clinical Trial Team (CTT).

Main Activities
・ Lead CTT and report to TCO-Japan Head.
・ Lead the clinical trial protocol development/translation for local and global trials in collaboration with global Early Project Team (EPT) as well as Japan Project Team (JPT) in Japan.
・ Lead the start-up activities of clinical trials; preparation of clinical trial-related documents such as informed consent forms (ICFs), Investigators Brochures (IBs), etc.; handling the scientific aspects of regulatory processes, such as development of “Scientific Rationale” document of Clinical Trial Notification (CTN), responses to scientific questions from health authorities, etc.; clinical outsourcing specifications, CRO/vendor selection and management.
・ Build and manage effective working relationship with key investigators to optimize scientific quality/innovation of clinical study design, execution, reporting, and publication. Lead protocol training meetings and support CPOs when conducting regional trials.
・ Lead CTT members to adhere to the global standards of performance and quality. Chair CTT meetings, report study progresses and issues with a resolution plan. Manage trial-level interactions with monitoring teams and other relevant functions when necessary.
・ Lead the medical/scientific review, final analysis and interpretation of clinical trial data, including development of clinical study reports, publications, etc., in collaboration with Clinical Project Leader (CPL) and JPT.
・ For local trials, prepare and run dose escalation meetings with investigators. Coordinate the real-time availability of qualified clinical trial data to provide consolidated information to dose escalation meetings.
・ Forecast trial resource needs (external costs): Be accountable for the development, management and tracking of trial budget working closely with CRO Management, Trial Forecast Managers, and Program Managers. Be accountable for accuracy of trial information in all trial databases and tracking systems.
・ Contribute to JPT and EPT by updating clinical trial status and providing clinical trial data.
・ Contribute to functional center of excellence in clinical trial execution by developing and/or improving process standards and tools to achieve excellence in trial operations and management.
・ Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures.
・ 100% timely delivery of all training requirements including compliance.

Requirements
Qualifications
・ Education: Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. Ph.D preferred.
・ Languages: Fluent Japanese for verbal and written communication. Good English for verbal and written communication
TOEIC >= 800

Experience/Professional Requirement
・ > 4 years technical, operational and management experiences in planning, executing, reporting and publishing clinical studies in pharmaceutical company or contract research organization.
・ Experiences in oncology early clinical development preferred.
・ Good knowledge of Good Clinical Practice, clinical trial design, and drug development processes including regulatory processes.
・ Hands-on experiences in data cleaning and analysis recommended.
・ Basic knowledge of oncology/hematology.
・ Good communication and team management skills.

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