MAIN PURPOSE OF ROLE：
・Leads/supervises a team of 2 or more professionals.
・First level manager of a work team that could comprise professionals, technical and/or administrative staff.
・Typically without budget or hire/fire authority.
・Focuses on mentoring, coaching, and coordination of PMDA Inspection Readiness.
・Primary responsibility is ensuring implementation of quality plan at every stage of the Clinical Trial process/operations.
・Oversee Foreign Data Submission projects
・Implement clinical quality assurance regulations.
・Write and revise standard operating procedures and working instructions.
・Support and facilitate audits and regulatory inspections, including PMS, local Japan studies, global studies Japan participates in and Foreign Data Submissions
・Supports study teams as a resource for compliance to regulations, procedures
・Ensure that standards are met and report potential issues either with quality or reliability of testing procedures.
・Lead implementation of new regulations.
・May support quality training.
・May interact with global teams
・Business Level English
・Deep knowledge of GCP
・At least Bachelors degree
・more than 5 years of clinical study management, project management in Medical Device, Pharma, or CRO
*English skill is highly required.