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新着求人 治験薬管理  (FC-63)
募集職種 国内系製薬企業の Clinical Sample Manager
勤務地 東京
会社概要 非公開
求人要件 【募集要項】
This position within Clinical Biomarker and Companion Diagnostic group resides in Biomarker department. This position is responsible to manage clinical samples collected from Daiichi Sankyo clinical trials. This position will act as a central point of contact between the Biomarker group, clinical teams and CROs to operate central sample management system.
Works closely with cross-functional study team to implement and operationalize clinical trials. Supports the creation of documentation related to clinical sample acquisition and management in clinical trials. Oversee master/country/site level informed consent languages related to the sample management and handle the clinical samples in accordance with the informed consent language and status. Build and maintain central clinical sample management system in collaboration with specialized vendor to monitor sample tracking and inventory data of all ** clinical trials for maintaining compliant operation and data integrity. Support sample management concern during the execution of a clinical trial protocol. Supports biomarker and translational research sample tracking, assessing and requirements. Manages central laboratory and specialty vendors and ensure smooth laboratory operations and timely clinical samples and data transfers. Oversees clinical samples inventories, utilization and destruction at a single sample level. Evaluates new capabilities aimed at collecting clinical biomarker samples.
Required Skills:
・Working knowledge of ICH/GCP and regulatory guidelines/directives.
・Working knowledge of CLIA/CAP regulations and GLP guidelines.
・A strong preference for a candidate having science background and broad technical experience of biological assays.
・Understanding of bioethics of human bio specimen collection and research.
・Ability to work independently as well as collaboratively in a matrixed team environment.
・Excellent written and verbal communication and presentation skills in small and large group settings.
・Ability to adjust priorities in a fast paced environment.
・Strong organizational and networking skills.
Education and Experience:
・PhD in biological sciences or related field.
・Must have at least 5 years industry experience in clinical sample management.
・Experience overseeing the clinical sample management at CROs is highly preferred.
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