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, 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
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 English (Speaking level 7 or above, Achieve common understanding at the context level)
【キャリアレベル / Career Level】
D
【勤務地 / Work Location】
Osaka or Tokyo
Date Posted
25-1月-2024Closing Date
-
Tokyo AstraZeneca Full timeDescription · Medical Communication Scientist (MCS) is a role name in AZKK and is generally known as "medical writer". MCS is responsible for the authoring of clinical-regulatory documents and submission packages that communicate the evidence base of product knowledge in a credi ...
-
Tokyo AstraZeneca Full timeDescription · Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that: · ・The rights and well-being of human subjects are pro ...
-
Koto City CSL Behring Full timePosition Purpose: · The Clinical Compliance Operations (CCO) Manager is a position within Clinical Development Operations, R&D Japan responsible for supporting the Clinical Research & Development, Clinical Operations Tokyo and Project Management to provide therapeutically aligne ...
-
Tokyo AstraZeneca Full timeDescription · Lead, Japan Clinical Operation Program (JPD, Lead) is accountable/responsible for leading the project planning for clinical operation in Japan R&D. The span of activities is broad covering clinical activities in both early and late drug development, registration/su ...
-
Tokyo Alexion Pharmaceuticals Full timeThis is what you will do: · The Senior Manager, Project Management is accountable for the generation and maintenance of program timeline for Japan local portion including Advisory Board meeting, internal governance endorsements, PMDA consultation, J-CTN, clinical studies, regula ...
-
Product Manager
3週間前
Tokyo BoostDraft Full timeAbout BoostDraft · BoostDraft is a software engineering company that develops IDE for documents. It was founded by MIT and Stanford grad students, developing an assisted document editor for documents. It is a new document editor that employs error checking, reference checking and ...
-
Tokyo Abbott OTHERAbbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmac ...
-
SW Project Manager
1週間前
Tokyo Isearch worldwide PermanentResponsibilities:The SW Project Manager is responsible of managing the planning and technical activities of the software development from the design phase till the complete integration, validation & start of production of the projects. · Contributes to the definition of the softw ...
-
Tokyo Foreign, Commonwealth & Development Office jobs.contract_type_full_time, PermanentThe British Government is an inclusive and diversity-friendly employer. We value difference, promote equality and challenge discrimination, enhancing our organisational capability. We welcome and encourage applications from people of all backgrounds. We do not discriminate on the ...
-
Project Manager
5日前
Tokyo Isearch worldwide Permanent当社のクライアントは、自動車用アクティブ・セーフティー・アンド・エレクトロニクス製品/テクノロジーの幅広い分野で、日本でのプレゼンスの高い欧州の自動車エレクトロニクス部品メーカーです。 · 仕事内容: · *開始からSOP、テストおよび評価、実際の車両のシミュレーションまで、ADASプロジェクトを担当します。 · *プロジェクトの要件とリソース、予算、開発、タイミングと配信を定義し、推進する。 · * R&Dコアチームを推進し、すべてのR&Dチームとプロジェクトの整合性を確保します。 · プロジェクトのR&Dスコープと実装に関連するプロセスとすべての変更 ...
-
Shinjuku Bose Full timeJob Description · The Global R&D Division Automotive Amplifier Development team is looking for an electrical Engineer for the development of automotive audio amplifiers. You will work closely together with customers, internal engineering teams and external engineering partners to ...
-
Project Manager
7日前
Tokyo Isearch worldwide PermanentOur client is a well-established European Automotive Electronics manufacturer expanding its operations in Japan and worldwide, offering a fantastic work-life balance and a vibrant work environment. · Position Overview:Lead project management for the development of next-generation ...
-
Lunar Scientist
2週間前
Tokyo ispace, inc.We are seeking a highly skilled and experienced lunar scientist specialising in landing site selection to join our dynamic multi-disciplinary team at ispace inc. The successful candidate will play a pivotal role in identifying and evaluating optimal lunar landing sites for our up ...
-
account manager
2週間前
Tokyo Lubrizol CorporationACCOUNTABILITY: · The purpose of this role is to deliver value to customers by providing service in commercial skills ensuring sustained growth of profitable sales which are aligned with our areas of market focus. Contacts assigned customer accounts or prospects to sell Lubrizol' ...
-
Tokyo CotyTHE ROLE · Employment Type: Full Time · Division: Japan Marketing, Consumer Beauty Division · Job Title: Marketing Manager · Reporting to: Senior Sales Manager, Consumer Beauty · Direct Reports: 4 · Collaborators: Regional Marketing Team + Local Sales Team + Global Brand Tea ...
-
Director Sales
5日前
Tokyo Arrow Electronics Japan K.K. Full timeDescription · : POSITION SUMMARY · This position is focused on growing the Engineering R&D (ER&D) / Product Engineering Services (PES) business in Japan, selling to Fortune500 customers within the defined territory. · Head sales and establish einfochips business/brand in Jap ...
-
Tokyo BASFO bjectives of the Position · The main coordinator and provider of first level technical support for Japanese & Korean customers · Collaborate with the sales organization, regional and global teams to drive business growth · Drive innovation and support business development for ...
-
Director Sales
4日前
Tokyo Arrow Electronics OTHERPosition: · Director Sales - APAC HeadJob Description: · POSITION SUMMARY · This position is focused on growing the Engineering R&D (ER&D) / Product Engineering Services (PES) business in Japan, selling to Fortune500 customers within the defined territory. · Head sales and estab ...
-
Shinjuku cotyCoty is a world leader in beauty and home to an illustrious roster of cosmetic, skincare and fragrance brands. And our company has a mission: to challenge the definition of beauty, to encourage authenticity and celebrate diversity. Because to us at Coty, beauty isn't about confor ...
-
Tokyo Valeo Full timeValeo is a tech global company, designing breakthrough solutions to reinvent the mobility. We are an automotive supplier partner to automakers and new mobility actors worldwide. Our vision? Invent a greener and more secured mobility, thanks to solutions focusing on intuitive driv ...
