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新着求人 臨床開発
募集職種 外資製薬メーカー 医薬開発本部クリニカルオペレーションズジャパンサイトマネジメント サイトモニタリングリード(スタッフレベル) /東京 の求人(15417)
勤務地 東京
会社概要 非公開
求人要件 As a member of trial team, provide and maintain oversight and guidance related to site monitoring activities throughout the course of a trial, to safeguard the protection of the trial subject, reliability of the trial results, compliance with study protocol, ICH-GCP and applicable regulations and ensure inspection readiness at all times.
Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the site management.
Provide operational expertise to the trial team on the site monitoring approach for the trial. Oversee the implementation of the site monitoring approach to ensure trials are monitored based on BI SOPs, relevant regulations.
If assigned as a site monitor, to monitor study sites of clinical trials from Phase I to Phase IV in Japan with the target to optimally address speed, quality and efficiency within the definitions set by legal and regulatory boundaries and ethical standards.
Ensure proper implementation of BI SOPs and systems for clinical trial related activities; contribute to continuous improvement within COJ for quality, efficiency and productivity.


Ensure delivery of clinical trials (from trial preparation to trial closure and reporting) in terms of
Trial level;
1) Preparation
Deliver site monitoring approach for the trial
・ Develop Trial Level Monitoring Manual and provide related input into trial plans, processes (e.g. trial risk assessment, Trial ISF/TMF, IMP management,
Supplier selection such as central imaging or laboratory) and documentation (e.g. input into CTP, IQRMP, IC and develop SFQ and other relevant site logs/forms such as source data status report, etc.).
Deliver site monitoring oversight plan for the trial:
・ Develop Site monitoring oversight plan and provide related input into trial level supplier oversight plan.
Ensure appropriate training:
・ Provide input into trial training plan and develop and deliver trial-specific training for Clinical Research Associates (CRAs).
Support streamlined data collection:
・ Provide input into eCRF
・ Support development of checklists/templates (as appropriate) and support IRT set-up (input into IRT requirements/set-up and conduct UAT)
・ Participate as appropriate in trial team meetings, International/regional investigator meetings and Drug supply meetings

2) Conduct
Oversee site monitoring activities in the trial
・ Issue management / oversight on trial level: review and assess site issues, escalate to CTL as appropriate, prepare for trial oversight/MQR meetings and follow up on further actions with countries when applicable
・ Pre-identify important protocol deviations from site issues/deviations for CTL(and TSTAT)or CTM to take final decision.
・ Proactive risk mitigation: perform regular risk indicator review as applicable and determine and follow up on required actions
・ Maintain site monitoring approach for the trial and update Trial Level Monitoring Manual, site monitoring oversight plan and other core trial documents such as ISF templates etc. as required
・ Conduct process and site quality performance monitoring and checkpoint calls or visits with the CRAs in a trial according to the site monitoring oversight plan, implement follow-up actions and escalation as required

3) Site close-out
Coordinate DBL planning with Trial Team and countries.
Support compilation and review of the quality section for the clinical trial report for site monitoring activities.

4) All phases
Facilitate communication and training related to site monitoring in the trial:
・ Communication with CTMs, CRAs, perform re-training etc.
・ Participate, prepare input and (co-)lead trial oversight meetings
必要要件 ・Proven track-record of solid site monitoring experience covering at a minimum 5 years of CRA experience and all stages of clinical trials (i.e. site selection, initiation, conduct and close-out). trial management experience is a plus
・Have capabilities as a Site Monitoring Lead to oversee the implementation of the site monitoring approach for the trial.
・In-depth knowledge of International Conference on Harmonization (ICH) regulations and Good Clinical Practice (GCP) and understanding of legal/regulatory environment as it pertains to major regulatory authorities and relevant directives/regulations.

・Solid project management and internal/external communication skills.

・Capable of performing site monitoring activities (CRA responsibility) at any stage of a clinical trial if required

fluent in verbal, and written communication English
年収 能力、経験を考慮の上、当社規程により優遇
募集背景 非公開
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