Clinical Site Manager II（後期フェーズ/臨床開発モニター/ Site Monitor/ CRA）

求人名 Clinical Site Manager II（後期フェーズ/臨床開発モニター/ Site Monitor/ CRA） 勤務地 Nihonbashi, Tokyo 事業部 Clinical Operations, Quantitative Sciences and China Development 雇用形態 正社員 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. （HP: Learn more about Astellas ） Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. 【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. 【職務の内容 / Essential Job Responsibilities 】 （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. 【応募要件 / Qualifications 】 ＜必須 / Required ＞ • 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 / Preferred ＞ • 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 【応募書類 / Application Documents】 和文履歴書・和文職務経歴書・英文レジュメ Both Japanese and English Resumes are needed 【選考プロセス / Selection details】 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. 【勤務地 / Location】 （雇入れ直後） 東京都中央区　アステラス製薬　日本橋事業所　本社 Nihonbashi, Tokyo （変更の範囲） 会社の定める事業場および自宅 【勤務開始日 / Start Date】 応相談 Will be decided according to the candidate's flexibility 【契約期間 / Contract Duration】 期間の定めなし Not limited to specified period 【試用期間 / Probation Period】 試用期間原則なし No probation period in principle 【給与 / Salary】 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 ①Base salary: will be decided by the candidate's experience, skill and capability. ②When Discretionary Work System is applied: Discretionary work allowance will be paid.(50,000～100,000yen, based on the Grade) 【昇給 / Salary Raise】 有り 【賞与 / Bonus】 有り 【諸手当 / Allowance】 裁量労働手当、住宅手当、通勤手当　等 Discretionary work allowance, Housing allowance, Commutation allowance, etc. 【勤務時間 / Working Hours】 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 8:45～17:45（Mon～Thu）、8:45～16:00（Fri） Discretionary Work System 【休日 / Holidays】 完全週休２日制（土曜・日曜）、祝日、5月1日、夏季、年末年始 Weekends(Sat and Sun), holidays, May 1st, summer vacation, New Year holidays 【休暇 / Vacation Leave】 年次有給休暇、育児休業制度、介護休業制度　等 Annual paid leave, childcare leave system, nursing care leave system, etc. 【福利厚生 / Welfare】 雇用保険、労災保険、厚生年金、健康保険、共済会制度、社宅制度、持株会制度、財形貯蓄制度　等 Employment Insurance, Industrial Accident Compensation Insurance, Welfare Pension Insurance, Health Insurance, Mutual Aid Association System, Company Housing System, Employee Shareholder Association System, Property Accumulation Savings System 【アステラス製薬　採用サイト/ Career web site】 For more information about Astellas, please visit our career web site. "We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law." 【What awaits you at Astellas? 】 •Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. •Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. •Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. •A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. 【Our Organizational Values and Behaviors】 Values: Innovation, Integrity and Impact sit at the heart of what we do. Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.