クリニカル・クオリティ・プロジェクトマネージャー

Job Details

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.
MAIN RESPONSIBILITIES:
・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

<応募要件>

・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.

Job application

Apex delivers strong profile and highly skilled candidates that match the job description requirements. Their candidate know how, network and experience helped us to initiate contact and integrate the candidate into our company. We are very happy with the candidate selected by Apex. K.K. consulting service. Thank you for the professional recruitment consulting service throughout the selection and follow up. We really appreciated it and strongly recommend Apex.

APAC Head of Supply Chain

Global Healthcare Company