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Data Manager

シミックホールディングス株式会社

Duties

We are responsible for promoting the development of data management for clinical trial data collected from medical devices and creating a series of tasks such as data collection and analysis, as well as technical support for manufacturing and design of medical devices. We also handle a wide range of tasks such as consultation with clients, creating DM plan documents, managing the schedule of project management, and extensive work such as creating checklists and digitizing data. In addition, we handle tasks such as preparing data for electronic submission, preparing for inspections, and tasks for employees such as training and specialization, as well as specialized work such as promoting the flow of data from upstream to downstream in project management, and ensuring the quality of data.

Requirements

・Experience of practical work in data management for medical devices and CRO for 2 years or more ・Clinical window work ・Creating DM plan documents ・EDC support ・Judgment of CRF requirements ・Data validation spec (re-examination basis) creation ・Experience in regular reporting of safety-related data and meeting-related work

Welcomed Skills

・Those who want to aim for the future as a data manager and have a sense of mission ・Those who have English skills (can be involved in international cases, such as CMIC Group's CMIC Data Science Vietnam and CMIC Korea) ・Those who have practical experience with Excel macros and Access ・Those who have practical experience in programming ・Those who have practical experience in data-based design

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