Regulatory & Start Up Specialist, Fsp

hace 23 horas

Buenos Aires, Argentina Novasyte A tiempo completo

We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role What You´ll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. - Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. - Prepare site regulatory documents, reviewing for completeness and accuracy. - Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. - Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. - Provide local expertise to SAMs and project team during initial and on-going project timeline planning. - Perform quality control of documents provided by sites. - May have direct contact with sponsors on specific initiatives. What Will Help You Succeed - +2 years clinical research experience submitting clinical procedures to the MoH (ISP). - Health Sciences degree - +1 year experience handling the "FEFYM" and “CABA” portal when submitting clinical procedures - Advanced command of English language. - Desirable experience in imports/exports that correspond to activities subsequent to the authorization of a clinical protocol in the country. - Desirable experience in contract negotiations with research sites. - #LI-AA8_ IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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