• Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues • Assesses site processes • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • Supports subject/patient recruitment, retention and awareness strategies • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met