07 ago
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Syneos Health
|
Santiago
07 ago
Syneos Health
Santiago
Clinical Trial Manager with experience working with United States as a CTM - Argentina, Brazil, Chile, Colombia or Mexico Home Based Updated: Today Location: Las Condes, RM, Chile Job ID: -OTHLOC-7324-2DR Description Clinical Trial Manager with experience working with United States as a CTM – responsible for overseeing site qualification, initiation, monitoring and close‑out activities for multi‑country studies. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiological Practices (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, with guidance, 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. For the Clinical Monitoring/Site Management Plan (CMP/SMP): 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 Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines Util
📌 Clinical Trial Manager with experience working with United States as a CTM - Argentina, Brazil,[...] (Santiago)
🏢 Syneos Health
📍 Santiago