FSP - Regulatory & Start Up Specialist
hace 2 semanas
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 Functions Under general supervision, serve as Single 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 and provide feedback to management on site performance metrics. Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. 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. Qualifications Bachelor's Degree Life science or related field Between 1-2 years of relevant experience working in the regulatory department in Argentina: Local and regional committees - Initial submission, Amendments, Response to Pending Issues. You'll be the nexus between the site and the ECs. ANMAT and CCIS - Knowledge of Inclusion of centers (EFCA2) is valuable ICF - Country and Site Specific Customization Essential Documents Collection TMF Update Trackers and Check lists. Advanced level of English Ability to work in a team IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at #J-18808-Ljbffr
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Regulatory & Start Up Specialist, Fsp
hace 3 días
Buenos Aires, Argentina Novasyte A tiempo completoWe 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....
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Fsp - Regulatory & Start Up Specialist
hace 3 días
Buenos Aires, Argentina IQVIA A tiempo completoThe **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...
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FSP - Regulatory & Start Up Specialist
hace 3 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoOverview The 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. May also include maintenance activities. Responsibilities...
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Regulatory & Start Up Specialist 1, Fsp
hace 22 horas
Buenos Aires, Argentina IQVIA A tiempo completoWe are currently looking for a Regulatory & Start Up Specialist to join our 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...
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Start-up Specialist
hace 5 días
Buenos Aires, Argentina Labcorp A tiempo completoRole 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...
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Study Start Up Manager
hace 3 semanas
Ciudad Autónoma De Buenos Aires, Argentina Medpace A tiempo completoOverview Our LATAM clinical trial activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Manager to join our Study Start Up team in Buenos Aires! This position plays a key role in the study start up process at Medpace. If you want an exciting career where you use your previous expertise and can develop...
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Site Specialist II, Study Start Up
hace 2 semanas
Buenos Aires, Argentina ICON A tiempo completoSite Specialist II, Study Start Up ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Site Specialist II (Study Start Up...
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Regulatory Start-Up Associate I
hace 2 semanas
Buenos Aires, Argentina ICON A tiempo completoA leading healthcare intelligence organization in Buenos Aires seeks a Study Start Up Associate I. You will support regulatory submissions, coordinate approvals, and assist study teams in document development. A bachelor's degree in life sciences is required, along with strong attention to detail and communication skills. Join a diverse team committed to...
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Senior Study Start-up
hace 2 días
Municipio de Rincón de los Sauces, Argentina Emmes Group A tiempo completoA leading clinical research organization is seeking a Study Start-up Associate Senior in Rincón de los Sauces, Argentina. This role is vital for coordinating regulatory submissions and ensuring compliance with local and global requirements in clinical trials. Ideal candidates will have over 6 years of experience in regulatory affairs across multiple...
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Start Up Manager
hace 2 semanas
Buenos Aires, Argentina ICON A tiempo completoStart Up Manager ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Manager, Study Start‑Up to join our diverse and...
