FSP - Regulatory & Start Up Specialist
hace 3 semanas
Overview 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 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 in 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. Function as 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 Checklists Advanced level of English Ability to work in a team #J-18808-Ljbffr
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FSP - Regulatory & Start Up Specialist
hace 2 semanas
Ciudad Autónoma De 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 Functions Under...
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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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Study Start-up Associate Senior
hace 2 días
Municipio de Rincón de los Sauces, Argentina Emmes Group A tiempo completoOverview Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Founded more than 47 years ago as Emmes, we entered the US government leading clinical research arena before expanding into public‑private partnerships and commercial biopharma. Our leading capabilities cover...
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Study Start Up Manager
hace 7 días
Rincón de los Sauces, 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. Responsibilities Efficiently manage and successfully execute all aspects of global...
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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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Remote Study Start-Up Specialist II
hace 2 semanas
San Carlos de Bariloche, Argentina ICON A tiempo completoA leading healthcare organization is seeking a Study Start Up Associate II to lead clinical trial initiation, ensuring regulatory compliance and collaboration with stakeholders. The ideal candidate holds a Bachelor's degree in life sciences, with at least 2 years of experience in clinical research. ICON offers a supportive work environment and attractive...
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Site Readiness and Regulatory Specialist I
hace 3 semanas
Municipio de Esquel, Argentina Fortrea A tiempo completoSite Readiness and Regulatory Specialist I Job Overview Primary contact with investigative sites during study maintenance and, when assigned, site startup activities, responsible for collecting required investigator and regulatory essential documents to ensure EC/IRB/Third body/Regulatory Authority submissions are made within the agreed timelines with...
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Experienced Regulatory Affairs Specialist
hace 4 semanas
Municipio de Avellaneda, Argentina Johnson & Johnson Innovative Medicine A tiempo completoExperienced Regulatory Affairs Specialist Join us as an Experienced Regulatory Affairs Specialist based in Buenos Aires, Argentina or Santiago, Chile. You will be responsible for end‑to‑end regulatory lifecycle management of labeling updates across Argentina, Chile, Uruguay, Paraguay, and Bolivia. Purpose Execute the complete labeling lifecycle...
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Regulatory Submissions Specialist
hace 4 semanas
Municipio de Esquel, Argentina IQVIA A tiempo completoOverview Regulatory Submissions Specialist (with Portuguese) This role requires working on National Holidays and weekends as needed. Responsibilities Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. Review, assess, and process safety data and information from various sources. Distribute reports/data to...
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IT Support Specialist
hace 2 días
Municipio de Esquel, Argentina Fundraise Up A tiempo completoIT Support Specialist (Entry-friendly, Training Provided) About Fundraise Up We're Fundraise Up - a global fundraising platform built to make donating to nonprofits fast, seamless, and accessible to all. Every month, our technology powers tens of millions of dollars in donations across the globe. We focus on innovation that directly impacts results: faster...