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東京都の臨床開発・薬事の求人136件応募資格・募集要項・仕事内容を見る
Clinical Trial Manager
- 給与
- 記載なし
- 勤務地
- 東京都中央区
- 休日
- 完全週休２日制（土曜・日曜）
- 雇用形態
- 正社員
どんな仕事かAIによる生成
担当する治験の計画、立ち上げ、実施を支援または主導し、治験チームやベンダーと連携して運営を進めるポジションです。治験の予算、スケジュール、リソースの管理や、試験関連資料・データ・品質の管理も担当します。
この求人に応募
応募資格
必須
- BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience.
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
- Requires project management skills and trial leadership ability.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
- Moderate (~25%) travel required.
歓迎
- Advanced Degree
募集要項最終確認 10/11
- 職種
- 臨床開発・薬事
- 雇用形態
- Employment Class: Permanent期間の定めなし試用期間原則なし
- 給与
- 記載なし
- 給与の詳細
- ①基本給：当人の経歴・技術・技能等を考慮して決定②裁量労働制の場合：裁量労働手当として職務グレードに応じて50,000～100,000円支給③フレックスタイム制の場合：月間の所定労働時間を超えて勤務する時間に対して時間外勤務手当を支給有り有り
- 手当
- 裁量労働手当50,000～100,000円住宅手当通勤手当
- 勤務地
- 東京都中央区 アステラス製薬 日本橋事業所 本社
- 転勤
- 会社の定める事業場および自宅
- 働き方
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home.Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
- 勤務時間
- 8:45～17:45（月～木）、8:45～16:00（金）、裁量労働制裁量労働制の場合、所定労働時間を働いたものとみなす
- 休日・休暇
- 完全週休２日制（土曜・日曜）祝日5月1日夏季年末年始年次有給休暇育児休業制度介護休業制度
- 福利厚生
- 共済会制度、社宅制度、持株会制度、財形貯蓄制度 等
- 社会保険
- 雇用保険、労災保険、厚生年金、健康保険
- 業務の変更の範囲
- 会社内での全ての業務
- 就業場所の変更の範囲
- 会社の定める事業場および自宅
- 学歴
- 大学卒業以上
- 選考の流れ
- 書類選考 → 1次面接 → 最終面接※変更の可能性もございますので、予めご了承下さい。CV screening → First interview → Final interview*Please be advised that there might be a change in the process.
- 掲載日
- 2026/10/11 09:00（2日前）
- 最終確認
- 2026/10/11 19:20（2日前）
仕事内容
募集の背景 / Purpose & Scope
- This position is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
- This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
- Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.
雇入れ直後
- Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
- Leads or supports cross-functional trial teams, including vendors.
- Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders.
- Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
- Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
- Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
- Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
- Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
- Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
- Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
- Provide oversight and direction to trial team members for trial deliverables.
- Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems.
- Ensure quality and completeness of TMF for assigned clinical trials.
- Participates in inspection readiness activities including coordination of clinical trial team deliverables.
- Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
- Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.
変更の範囲
- 会社内での全ての業務
この求人は、アステラス製薬株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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募集元の採用ページから応募できます
応募はアステラス製薬株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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応募資格の語から探す
- 英語12,462
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