General Information
Job Advert Title: Clinical Site Manager Ⅲ（臨床開発モニター/ Site Monitor/ CRA）
Location: Nihonbashi, Tokyo
Division: Clinical Operations, Quantitative Sciences and China Development
Employment Class: Permanent
Description
Learn more about Astellas）
【募集の背景 / Purpose & Scope】
A Clinical Site Manager III (CSM III) 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. Further, this position could be required as the management of other CSMs. 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 ≥10 years of experience in pharmaceutical related drug development or direct equivalent experience.
•Ten 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 5 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
•Experience as the Lead CRA or equivalent Leader role in the Oncology area with abroad members
•Experience as the people manager for team members regardless of regional or global members
•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.
•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
•Experience as the Study Manager or Project Manager role
•Experience as the people manager of global members
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