.IQVIA Biotech, a global full service CRO providing flexible and tailored clinical solutions to smaller biotech companies, is seeking additional talent within our **Site File Operations team**. Our **Site File Specialist II **opportunity requires: BS/BA/BSc, or equivalent, plus 2 years of related experience; regulatory document review experience preferred. Equivalent combination of education, training and experience**BASIC FUNCTIONS**:Responsible for the quality and regulatory compliance of Investigator Site Files (ISF) during the file maintenance period of the study. Work with both internal and external teams to assure good communication regarding documentation processing. Assure documents maintained for a study are 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.A Regional File Maintenance Specialist II will work in conjunction with or under the supervision of a Lead and/or Manager Level. Site File Specialist may be assigned to support start-up projects, as needed.**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:- Performs ad -hoc reviews of investigator study files for expired documents.- Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required and regionally applicable.- Communicates directly with the site, with the Site File Associates/Specialists, or local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents. May tracks any action items to CRAs/sites in CTMS.- Oversees the Site File Associate(s)- Reviews eTMF reports on a regular basis to ensure all documents have been filed according to IQVIA Biotech SOPs.- Ensure Periodic Site File Review are completed as per the IQVIA Biotech SOPs.- May review documents received from sites, IRBs/ECs and CRAs to ensure compliance with GCP and IQVIA Biotech's standard operating procedures from maintenance through close-out phase.- In NA, supports the review of site specific ICFs as changes occur during the study. Completes ICF checklists and files IRB approved ICFs throughout the study. Maintains accurate and complete site specific ICF template tracking.- Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).- Responsible to send updated documents (e.G. 1572, FDF) to client on a monthly basis as required.- Responsible for review of the ongoing IRB/Ethic Committee (EC) documentation (i.E. IRB continuing review, Amendment approval) and update tracking system as necessary and as applicable to region.- Follows the appropriate IQVIA Biotech and/or sponsor SOPs during conduct of the study.- Ensures all project documentation is appropriately filed per IQVIA Biotech SOPs, or Sponsor SOPs as required