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新着求人 モニター  (MM-54)
募集職種 外資系製薬企業の CRAサイトマネジメント
勤務地 東京
会社概要 非公開
求人要件 【Basic purpose of the job】
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.
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 ** SOPs, relevant regulations.
・Coordination and oversight; setting priorities, processing and analyzing data and information
・Achievement and performance driven
・Deciding, problem solving, independence
・Communication, cultural sensitivity, clear and transparent, internal and external focus, collaboration and team work
・Digital solutions for trial management Driven to learn and grow
・Solid knowledge in and experience with site monitoring processes and expertise with relevant tools and systems (e.g. Electronic Data Capture (EDC), Site Management System (SMS)).
・Capable of performing site monitoring activities (CRA responsibility) at any stage of a clinical trial if required
【computer skills】
Excel, Word, Outlook, Powerpoint, Internet and ** systems
fluent in verbal, and written communication English
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