】【R&D】Study Manager, R&D, Development Operations, Late Development Oncology Clinical Operation 1
10時間前
Description
Responsible for leading and managing clinical delivery team of contributing experts to operationally deliver defined clinical studies, or clinical project work package / activities to time, cost and appropriate quality in Japan R&D.
Clinical Operations is the organisational home for the operational delivery and programme and project management of clinical projects, drug and non-drug.
■ 応募資格(経験、資格等)/ Qualification (Experience & Skill etc.)
【経験 / Experience】
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
Understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g. ICH-GCP/J-GCP, local regulations, study management
Good experience of clinical development / drug development process in various phases of development and therapy areas.
Working experiences in Clinical Development/ Quality Assurance, especially Oncology experience
Knowledge of process improvement methodology such as Lean Sigma/Change Management
【資格 / License】
Bachelor's Degree in Science or related discipline
Medical or biological sciences or discipline associated with clinical research.
Advanced degree is preferred.
【能力 / Skill-set】
Excellent Communication and relationship building skills
Proven ability to prioritize and manage multiple tasks with conflicting deadlines
Excellent interpersonal skills and proven ability to facilitate team building and team work
Proactively identifies risks and issues and possible solutions
Demonstrates ability to prepare and deliver study related training materials
Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
Demonstrates professionalism and mutual respect
Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
Proven learning agility
Basic knowledge and experience of quality management
Critical/Logical thinking
Project management certification
Ability to interact widely and effectively within the company at all levels. Good networking skills
In-depth knowledge of clinical and drug development process
Fiscal and financial awareness
【語学 / Language】
英語 English:Business Level (Comfortable speaking in conference setting, Achieve common understanding at the context level)
日本語: Native/Proficient
【キャリアレベル / Career Level】
D
【勤務地 / Work Location】
Osaka or Tokyo
Date Posted
15-3月-2024Closing Date
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