Job Description

Time Type: Full time
Job Requisition ID: R-278464

The Role:
  • Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials.
  • Manages case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility.
  • Manages the delivery of the Safety Reporting Plans; identifies, implements, and monitors KPIs/KQIs across clinical case management activities;
  • Supports the preparation and conduct of PV and other GxP inspections and audits, as required.
  • Establishes, maintains, and/or ensures maintenance of clinical trial case management required documents, such as safety reporting plans and reporting responsibilities, in line with international and national regulatio...

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