Site File Operations Administrator – IQVIA Biotech

IQVIA – Richmond, VA – IQVIA Biotech is now hiring a Site File Administrator. BASIC FUNCTIONS: Responsible for maintaining IQVIA Biotech database(s) and assisting with TMF Operations Department efforts to ensure the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study. Work with both internal and external teams to ensure good communication regarding documentation processing. Assists with maintaining… documents in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by IQVIA Biotech and its clients. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Updates IQVIA Biotech database(s) as documents are received by respective team members. Assists in saving site documents to the shared (G) drive and file using filing conventions. Documents study challenges and effectively communicate those to the…

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