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Clinical Site Manager （臨床開発モニター｜Site Monitor｜CRA）

年収：800万～ 1200万

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部署・役職名	Clinical Site Manager （臨床開発モニター｜Site Monitor｜CRA）
職種	臨床開発 CRA（臨床開発モニター）
業種	医薬品メーカー
勤務地	東京都
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) in the study teams to ensure overall site management while performing trial related activities for assigned protocols. 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. 私たちアステラス製薬は、臨床開発におけるモニター職（Clinical Site Manager）を募集しています。アステラス製薬のモニター職は、臨床試験を管理運営するClinical Trial Lead (CTL,), Clinical Trial Manager (CTM,), Clinical Trial Specialist (CTS,), Study Start-Up Specialist (SSS)と連携して、施設での臨床試験の運営をサポート・モニタリングします。【職務の内容 / Essential Job Responsibilities】（雇入れ直後） • Ensure ongoing adequacy of site (facilities, staff) for trial conduct,. site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. • Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA • May participate in site feasibility and/or pre-trial site assessment visits. Attends/participates in investigator meetings as needed. • 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. •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. • 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. • 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. アステラス製薬のモニター職は、主に日本で実施する臨床試験において、治験開始準備～終了までのモニタリング業務を行います。（変更の範囲）会社内での全ての業務【組織 / Organizational Context】 Reports to the regional Site Management Lead Early or Late Stage Site Monitoring & Management Organization. This position may provide mentoring/support/strategy/information to less experienced clinical site managers and may provide oversight for contract team members in the assigned studies. A matrix relationship to the study teams is essential in effective execution of this role. This position may be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines. 今回募集しているアステラス製薬のClinical Site Manager（モニター職）は、早期臨床開発を担当します。Study teamと連携の上、試験の遂行に貢献します。複数のプロトコルと複数の施設を担当いただきます。また、経験の浅いモニターの教育指導も期待されています。
応募資格	【必須（MUST）】 • BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience. • Five years site monitoring and/or site management experience. • A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant 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. • Good written and oral communication 【歓迎（WANT）】 • 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
アピールポイント	自社サービス・製品あり日系グローバル企業女性管理職実績あり上場企業従業員数1000人以上シェアトップクラス創立30年以上年間休日120日以上産休・育休取得実績あり教育・研修制度充実完全土日休みフレックスタイム月平均残業時間20時間以内
受動喫煙対策	屋内禁煙
更新日	2024/09/03
求人番号	3817147

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アステラス製薬株式会社

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