1 assistant support jobs found in Reading, PA

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 regulations, guidelines, and internal standards. Oversee the Vendors to ensure GSPV...