Tóm tắt công việc
Nghề | Nghề yêu cầu kỹ thuật (Bán hàng, Thiết kế, Phát triển, Quản lý sản xuất)/Phát triển, Nghiên cứu, Thực nghiệm, Quản lý dự án |
---|---|
Ngành | Y tế/ Các ngành y tế khác |
Hình thái tuyển dụng | Chưa phân loại |
Chức vụ | Khác |
Số lượng tuyển dụng | 1 người |
Ngày muốn vào làm | - |
Kỹ năng ngôn ngữ cần thiết |
Tiếng Nhật (Thành thạo) Tiếng Anh (Giao tiếp kinh doanh) |
Ngôn ngữ có thể sử dụng | - |
Thời gian làm việc | Khác |
Ngày nghỉ / Phúc lợi y tế | |
Hỗ trợ xin visa | - |
Nhân viên người nước ngoài | - |
Chi tiết công việc
Company Overview
Senior Data Manager - Well Respected Global CRO Company
Job Description
Strong oral and written communication skills, with ability to communicate effectively throughout all levels of the organization.
Demonstrated capability to set clear priorities and effectively manage multiple projects.
Pharmaceutical or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA & PMDA
Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms);
Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements;
Create and maintain Data Validation Plan;
Create Data Entry Guidelines;
Create Data Handling Plan;
Create Data Transfer Specification;
Develop and review Case Report Form (CRF), electronic and/or paper;
Develop database (DB) clinical trial data specifications, including CRF annotation, edit rules/checks, query logic and data validations;
Perform external data reconciliation in collaboration with programmers;
Develop test scripts and execution logs for User Acceptance Testing (UAT);
Perform training on study trials and create user guides;
Perform database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock;
Coordinate the archiving of study databases and related documents;
Database audit;
Perform SAE reconciliation;
Perform other activities as required;
Provide mentorship to junior members;
Working with project manager and cross functional team members to maintain project timeline and overall quality of deliveries.
Requirements
Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
Working knowledge of Clinical database applications.
Bachelor’s degree in clinical/pharmacy/biological/mathematical sciences or related field or nursing degree.
At least 2 years data management and/or related work experience in a medical device or pharmaceutical industry/company is preferred.
Ability to solve problems and work independently with general direction.
Về cuộc phỏng vấn
Địa chỉ liên lạc
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500 〜 800 ten thousand JPY