Job Advert Title: Clinical Site Manager II
Location: Nihonbashi, Tokyo
Division: Early Development
Employment Class: Permanent
Description
Development, Early Development, Clinical operation, Clinical study
【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。
【応募要件 / Qualifications】
＜必須 / Required＞
• 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 / 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
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
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)
③When Flextime System is applied: Overtime allowance will be paid for time worked in excess of prescribed working hours.
【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）、企画業務型裁量労働制
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】
https://re-jp.astellas.com/jp/recruit/newgraduates/
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."