Study Design & Data Science Manager

Location: Japan - Tokyo
Job Type: Permanent
Salary: 12000000 - 16000000 JPY
Job Function: Project Management
Reference: JO-191121-206131
Industry: Life Sciences & Healthcare
Sub-Industry: Pharmaceuticals

Company Overview

Global Pharma Maker

Job Description

・ Produce protocol concepts in collaboration with stakeholders
・ Comply with industry and company rules
・ Budget management of the project in charge
・ Leading and passing examination work in company RC
・ Acquire approval in response to inquiries from PMDA
・ Affiliate Study Design
・ Affiliate Study consultation support ・ Method proposal
・ Protocol creation with other stakeholders
・ Get approval of the created Protocol

Requirements

・ Knowledge of work related to pharmacy law
・ Knowledge of fair competition rules
・ Knowledge of laws and regulations related to pharmaceutical application
・ Work knowledge related to GPSP ministerial ordinance
・ Business knowledge related to GVP ministerial ordinance
・ Knowledge of clinical trial related laws and guidelines
・ Basic knowledge and correct understanding of statistics, experimental design
methods and epidemiological methods
・ Responsible for the medical research implementation plan as a research designer