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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 Site Manager II（後期フェーズ/臨床開発モニター/ Site Monitor/ CRA）
- 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）、祝日、5月1日、夏季、年末年始
- 雇用形態
- 正社員
どんな仕事かAIによる生成
A Clinical Site Manager II serves as the primary contact point between the Sponsor and the Investigational Site, managing site relationships and clinical trial delivery. The role covers site start-up, monitoring, site management and close-out, while ensuring compliance, data quality and inspection readiness. The position may provide mentoring and oversight to less experienced site managers and contract team members.
この求人に応募
応募資格
必須
- BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience CSM.
- Five years site monitoring and/or site management experience.
- Demonstrated ability to independently manage assigned sites, prioritize competing activities, resolve routine and complex site issues, and escalate risks appropriately with limited supervision.
- A minimum of 2 years of Oncology therapeutic area experience.
- Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong critical thinking and problem solving skills.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel up to 40% with overnight stay away from home.
- Proficient in speaking and writing English. Depending on hiring region, may also be required to be fluent in local language.
- Strong stakeholder management skills with investigators, site staff, cross-functional study team members, vendors/CROs, and regional/global functions.
- Good written and oral communication.
歓迎
- Experience working cross-functionally and in matrix teams
- Experience in executing Lead CSM role
- Experience mentoring more junior site monitors or site managers
- Experience working in early development studies
募集要項最終確認 10/11
- 職種
- 臨床開発・薬事
- 雇用形態
- Permanent期間の定めなし試用期間原則なし
- 役職
- This position may provide mentoring to less experienced site managers and may provide oversight for contract team members.May serve as Lead/sub-Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study.Provides mentoring, coaching, and practical guidance to less experienced CRAs/CSMs and supports consistent application of monitoring standards, systems, and inspection-readiness expectations.
- 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
- 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）、専門業務型 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
- 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
- 経験年数
- 2年以上
- 学歴
- 大学卒業以上
- 選考の流れ
- 書類選考 → 1次面接 → 2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 → 2nd 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
- A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols.
- Responsibilities may include assisting with or primary responsibility for:
- Site Selection
- Pre-trial assessment
- Site level Study Participant recruitment/retention plans
- Site Activation/Initiation
- On-site and remote monitoring
- Overall site relationship management in collaboration with other sponsor roles that interact with the site
- Close-out activities
- Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role.
雇入れ直後
- Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
- Develops meaningful site relationships through consistent collaborative communication and engagement.
- May participate in site feasibility and/or pre-trial site assessment visits.
- Attends/participates in investigator meetings as needed.
- May serve as Lead/sub-Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
- Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
- Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
- Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
- Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA.
- Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
- Ensures site non-IMP study supplies are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
- Oversees the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures validity and completeness of data collected at trial sites.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Provides mentoring, coaching, and practical guidance to less experienced CRAs/CSMs and supports consistent application of monitoring standards, systems, and inspection-readiness expectations.
- Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
- Independently identifies site-level quality, compliance, enrollment, and operational risks; develops mitigation plans in collaboration with the study team; and escalates issues in a timely, solution-oriented manner.
- Prepares trial sites for close out, conduct final close out visit.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- May be responsible for up to 10 sites across 2-3 protocols with a workload range aligned to country, modality, protocol complexity, monitoring model, and site activation/recruitment intensity.
変更の範囲
- 会社内での全ての業務
就業環境に関する要件 / Specific Physical or Environmental Requirements
- 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. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
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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