Regulatory & Start Up Specialist, Fsp

hace 7 días

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

  • Regulatory & Start Up Specialist, Fsp

    hace 2 días

    Buenos Aires, Argentina Blue Collar Scholars 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...

  • Fsp - Regulatory and Start Up Specialist 2 - Arg

    hace 2 semanas

    Buenos Aires, Argentina Wimbush & Associates, Inc. A tiempo completo

    Fsp - Regulatory and Start Up Specialist 2 - Arg IQVIA Job Overview The Regulatory & Start Up Specialist 2 will 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....

  • FSP - Sr. Regulatory and Start Up Specialist

    hace 3 semanas

    Buenos Aires, Argentina IQVIA LLC A tiempo completo

    FSP - Sr. Regulatory and Start Up Specialist page is loaded## FSP - Sr. Regulatory and Start Up Specialistlocations: Buenos Aires, Argentinatime type: Full timeposted on: Posted Todayjob requisition id: R Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international...

  • Fsp Sr. Regulatory and Start Up Specialist in Argentina

    hace 4 días

    Buenos Aires, Argentina Coding Giants A tiempo completo

    Fsp Sr. Regulatory and Start Up Specialist in Argentina IQVIA The Sr R regulatory and start‑up specialist will 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....

  • Fsp - Regulatory & Start Up Specialist

    hace 7 días

    Buenos Aires, Argentina IQVIA A tiempo completo

    The **R**egulatory and Start-Up Specialist**will 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. May also include maintenance activities. **Essential...

  • Start-up Specialist

    hace 4 días

    Buenos Aires, Argentina Remoteco A tiempo completo

    Role Description Study-Start-Up/QC Specialist: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to...

  • Remote Regulatory

    hace 4 semanas

    Buenos Aires, Argentina ibos consulting A tiempo completo

    A global consulting firm is seeking a Regulatory & Start Up Specialist for a home-based role. This position requires a minimum of 2 years of clinical research experience, particularly in submitting procedures to the Ministry of Health in Argentina. The ideal candidate will possess a Health Sciences degree, a strong command of English, and experience with MoH...

  • Start-up Specialist

    hace 3 horas

    Buenos Aires, Argentina Labcorp A tiempo completo

    **Job Overview**:** Role Description Study-Start-Up/QC Specialist**: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with...

  • Start-up Specialist

    hace 1 semana

    Buenos Aires, Argentina Labcorp A tiempo completo

    Role Description Study-Start-Up/QC Specialist: Purpose: Study Start Up/QC Specialist is responsible for country study start up (SSU) activities and performing quality review of essential documents. The SSU/QC Specialist is responsible for overseeing and leading SSU activities in collaboration with country team members (CLM and CRA) with the objective to...

  • Global Site Start Up Ii

    hace 7 días

    Buenos Aires, Argentina Parexel A tiempo completo

    **Parexel FSP** is looking for** Global Site Start-up II**in **Argentina**! **Job Summary** The Global Site Start-up II is accountable for the global execution of site activation for assigned clinical trials, performing responsibilities with moderate oversight. The Global Site Start-up II is accountable for ensuring site start-up is efficient, timely and...