Senior CRA (Country Lead Monitor)

Company Overview
Pharmaceuticals Company

Job Description
The senior Clinical Research Associate (Sr .CRA) is accountable and responsible for Country Lead Monitor for assigned oncology studies. The CLM leads assigned Japan local monitoring team and works in close collaboration with global study team. The Sr CRA all aspect of site management and monitoring activities for assigned applicable Phase I and all Phase II -IV clinical investigator sites as CLM. These global, complex studies are conducted with the standards set by our Global Development, according to Good Clinical Practices (ICH-GCP) and applicable regulatory and legal requirement. The CLM contributes a planning of appropriate Japan development program from clinical operational perspective as a member of Japan project team. In addition, the CLM acts as a leader not only the responsible monitoring team but also close collaboration with relevant functions, i.e. Clinical Development and Regulatory Affairs, etc.

Requirements
■At least 5 years clinical operations experience in the pharmaceutical industry and at least 1-2 years clinical operations experience in the Oncology Field
■At lease 2 years of clinical trail/study management as a leader experience preferred.
※The incumbent is responsible for management of Phase II-IV complex and global/Local clinical trials.
■This requires an in-depth knowledge of oncology field, Good Clinical Practices (GCP), federal reg

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