Clinical Compliance Operations Manager, R&D Japan

CSL Behring

Koto City, Tokyo

Position Purpose:

T he Clinical C o m pance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligned compliance support to study teams focusing on adherence to procedural/regulatory requirements and Corrective and Preventive Action ( CAPA) coordination to ensure inspection readiness.

Reporting Relationships:

T h i s p o s i t i on r ep o r t s t o t he Senior CCO Manager and w il l ha v e g l obal r espons i b ili t i es i n t he f o ll o wi ng l oca t i on: T o k y o

Main Responsibilities and Accountabilities:

1) P r o v i de compliance support, including quality and compliance advice/consultation, to the study programs conducted in Japan to ensure adherence with procedural/regulatory requirements and driving inspection readiness.

2) Manage Inspection Preparation activities for PMDA regulatory... More Detail

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