• Clinical Trials Statistical Programming Mgr will be responsible for all statistical programming and clinical programming activities for multiple clinical trials; support BLA filings and ensure data analysis quality and CDISC compliance.

• 統計プログラマーのチームを管理し、現在および将来の化合物や研究分野の臨床研究のプログラミング活動や分析をリードします

• Responsible for leading the following safety management tasks and building safety management operations across clinical and post-marketing areas

• Responsible for managing all clinical safety surveillance activities as CRO representative in collaboration with pharmaceutical sponsors
• Provide leadership within Pharmacovigilance to contribute to overall study execution while ensuring safety strategy, quality, compliance and operational excellence

• 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

• Line management of safety group at a world leading Med Device company
• Oversee management of safety reporting to PMDA

• 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。

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

• 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.

• 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