Tóm tắt công việc
Nghề | Nghề yêu cầu chuyên môn (Tư vấn, Tài chính, Bất động sản, Dịch vụ chuyên môn)/Dịch vụ chuyên môn (y tế, phúc lợi xã hội, giáo dục, hướng dẫn viên) |
---|---|
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
オンコロジー領域に強みを持つ、外資製薬メーカー※プロジェクト数は業界TOP3
Job Description
- Manage a cross functional team of clinical experts to operationally deliver defined clinical studies or assigned clinical project activities to time, cost and appropriate quality including documentations.
- Provide input into study start up activities (e.g. study feasibility, study specifications, vendor/partner contracts, authoring of clinical study protocols and budgeting including authorization and governance of payment).
- Oversee the delivery to plan of studies performed through external partners (such as Alliance partners, CROs, vendors and Academic Research Organizations) and to monitor progress, identify and solve operational issues.
- Lead and manage all activities related to site management and monitoring including the following with agreed timelines, agreed budget and company standard quality.
- Plan and deliver a site selection strategy
- Patient recruitment strategy including SMO managements
- Lead and manage CRAs including CRO CRAs to deliver clinical study data
- Develop and manage risk mitigation plans and contingency plans to execute site managements and monitoring from sites clarification to sites close on time.
- Manage the quality of clinical study data including queries and deviations and resolve issues as needed.
- Ensure the quality of monitoring visit reports focused on study specific contents.
- Lead activities associated with site audits in liaison with Clinical & Pharmacovigilance QA and contribute to regulatory inspection in the area of site management and monitoring
- Escalate issues related to site management and monitoring to an appropriate person and contribute to resolve.
Requirements
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
- At least 5 years experience from within the pharmaceutical industry or similar organization or academic experience.
- Extensive knowledge of clinical operations, project management tools and processes
- Good experience of clinical development / drug development process in various phases of development and therapy areas
- Developing partnering skills
- Influencing
- Financial/Fiscal Awareness and Supplier/Partnership Management
Về cuộc phỏng vấn
Địa chỉ liên lạc
Study Leader
RGF HR Agent
700 〜 1000 ten thousand JPY