• Responsible for the following Case processing tasks as a member of the clinical information or post-marketing drug or medical device safety information management project:

  - Receipt of information on adverse events, entry in database
  - Creation of case description (Japanese, English)
  - Primary evaluation of the necessity of reporting a defect to PMDA
  - Creation of adverse drug report
  - QC check

統計解析業務経験やシステム開発経験があり、更にチームマネジメント経験のある方を求めています。

コンサルティングファーム出身の代表が立ち上げたコンサルティングサービスを提供する新しいCRO企業です。

Provide expertise and engagement scalability by acting as liaison between the customer and

Professional Services.

• Responsible for guaranteeing quality and compliance of trials, identifying issues and leading root cause analysis and CAPA

• Prepare, record , verify and maintain complex SAS-based evaluation and reports of clinical trials data

• Responsible for design and execution of clinical trials within the haematology cell therapy business
• Lead clinical trials at a country level

• Data management activities across broad range of global clinical trials
• Work closely with US Office and sponsors to ensure effective and timely execution of project deliverables

• The GCP Auditor will be a critical team member who contributes to the implementation of a risk-based GCP audit program and provides oversight / management of the GCP consulting program.
• Promote continual improvement regarding customer satisfaction with emphasis on GCP consulting services.

You will support the management of investigative sites and ensure that all sites adhere to the requirements and regulations governing Clinical Research. You will support feasibility, study start-up, assisting sites during maintenance and closing out sites.

Working as the leader of a cross-functional study team and for a mix of sponsors. The Project Director is responsible for owning and achieving interim and final contractual deliverables for assigned projects/programs, according to the time, quality/scope and cost constraints.

• Responsible for conducting oversight of each project and/or trial level
• Responsible for guaranteeing the high quality of a trial, identifying potential issues and contributing to root cause analysis and CAPA

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  CTDライティングの作成.
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  プロジェクトチームのメディカルライティングにおける管理.

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  Collaborate with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.
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  Design and implement clinical protocols and data collection systems.

• Responsible for leading the following safety management tasks as a manager of the clinical and post-marketing safety:

  - Receipt of information on adverse events, entry in database
  - Creation of case description (Japanese, English)
  - Primary evaluation of the necessity of reporting a defect to PMDA
  - Creation of adverse drug report
  - QC check

• Prepares, conducts Quality Assurance audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g., Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken
• Responsible for guaranteeing quality and compliance of trials, identifying issues and leading root cause analysis and CAPA

• Responsible for management of Clinical Quality oversight of each project and/or trial level to ensure adherence to Quality & Compliance guidelines
• Responsible for guaranteeing the quality and compliance of a trial, identifying potential issues and contributing to root cause analysis and CAPA

• Lead data management operations across broad range of global clinical trials
• Act as project leader and functional lead as well as primary contact for sponsors

• Lead data management operations within Japan for global clinical trials
• Facilitate smooth operation of EDC activities for internal and external stakeholders

• Produce an manage SAS are met within the allocate timeline

As a Nutrition Specialist you will focus on formulate a nutrition strategy for our client by utilizing the knowledge of nutrition and building new relationships with academic experts.