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新着求人 臨床開発  (MRI-39)
募集職種 外資系製薬企業の Clinical Operations, Manager
勤務地 東京
会社概要 非公開
求人要件 【職務内容】
(High-level Description)
・ This position is responsible for the Line management of 5-10 people (may include Site Managers, Site Monitors, Clinical Trial Associates and Clinical Site Data Monitors), possibly across Japan, Korea and Taiwan.
・ Works in collaboration with RCO JKT line managers and head of RCO JKT to support and supervise all clinical trial activities conducted in Japan, Korea and Taiwan.
・ Works with GCO colleagues to ensure global alignment of study progress and processes.
Expected Areas of Competence
・ Technological expertise and understanding of the business process implications.
・ Exceptional organizational and planning skills and independent decision-making ability.
・ Anticipation of resources needs and allocation of resources in alignment with R&D priorities and objectives to ensure timely and accurate execution of clinical trials.
・ Resources assignment in alignment with project prioritization, based on skills and abilities within the team.
(Required knowledge/skills)
・ Knowledge equivalent to that attained with a Bachelor’s degree.
・ A minimum of 6 years pharmaceutical industry experience or equivalent.
・ Good understanding of the drug development process.
・ Advanced knowledge of clinical operations and systems.
・ An in-depth understanding of the clinical development process including regulations (local and international), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines.
・ Leadership experience (i.e. participation in task force, initiative or cross functional team); experience in mentoring and providing constructive feedback to others.
・ Strong English language capability.
(Gender Unquestioned)
Working Experience at Foreign Pharma Comapny(MUST)
=>Domestic Pharma Comapny(NG)
Have experiences Change Management/ Change Leadership(MUST)
People Management(Nice to have)
Have experiences CRO Management (Nice to have)
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