Clinical Site Manager II（早期フェーズ/臨床開発モニター/Site Monitor/CRA）

Role summary

Written by MyIslandJob from the job title and employer. See the employer's page for the full description.

The Clinical Site Manager II supports early-phase clinical trials in Japan, acting as the primary monitor and contact for assigned research sites. Responsibilities typically include site selection and initiation, feasibility assessment, monitoring visits, source-data verification, compliance oversight, issue resolution, essential document management, and communication with investigators and internal study teams. Candidates are generally expected to have several years of clinical research experience, preferably as a CRA or site monitor, with knowledge of ICH-GCP, Japanese clinical-trial regulations, and clinical data processes. Strong organizational, communication, problem-solving, and Japanese and English skills are important. Astellas will expect the successful candidate to work independently, manage multiple priorities, travel to sites when required, and maintain high standards of patient safety, data integrity, and study quality.

About the employer

Astellas Pharma Inc. is a Japan-based global pharmaceutical company headquartered in Tokyo, with operations across North America, Europe, and Asia. The company focuses on innovative medicines in areas including oncology, immunology, urology, neuroscience, ophthalmology, and rare diseases. Astellas invests heavily in research and development and conducts clinical trials worldwide to bring new treatments to patients with significant unmet medical needs. Its working environment combines Japanese corporate values with an international, science-driven culture. Employees often collaborate across countries and functions, including clinical development, regulatory affairs, medical affairs, commercial operations, and research. Astellas places strong emphasis on patient safety, scientific integrity, compliance, diversity, and innovation. The company’s early-phase clinical development teams support complex studies requiring close coordination with investigators, hospitals, vendors, and global project teams.