シニア臨床試験スペシャリスト（モニター職）
- 採用企業名
- 【東京/大阪 リモート勤務可】世界最大手医療機器メーカー
- 職種
-
メディカル・バイオ - 医療機器モニター
- 雇用形態
- 無期雇用
- 勤務地
-
大阪府 東京都
- 仕事内容
-
...
At the company you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
【A Day in the Life】
Responsibilities may include the following and other duties may be assigned.
Oversees, designs, plans and develops clinical evaluation research studies.
Prepares and authors protocols and patient record forms.
Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application.
Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
May be responsible for clinical supply operations, site and vendor selection.
People working within region/country may also have the responsibilities that include:
Represents the company from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
Builds and maitains optimal relationships and effective collaborations with various internal and external parties.
Drives local evidence dissemination & awareness.
【SPECIALIST CAREER STREAM】
Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
【DIFFERENTIATING FACTORS】
Autonomy: Seasoned individual contributor.Works independently under limited supervision to determine and develop approach to solutions.Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .Makes improvements of processes, systems or products to enhance performance of the job area.Analysis provided is in-depth in nature and often provides recommendations on process improvements.■休日：完全週休二日制, 土, 日, 祝日, 年末年始
- 求める経験
-
...
【Required Knowledge and Experience】
Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.■職種未経験者：不可
- 想定年収
- 760万円 - 1100万円
- 語学力
-
英語力：初級以上
