Sr. Site Activation Specialist in Argentina
hace 2 días
Sr. Site Activation Specialist in Argentina Novasyte The Sr. Site Activation 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. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area. Problems faced are general and may require understanding of broader set of issues but are not complex. 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 feasibility, site ID, 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 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 feasibility, site ID, regulatory and contractual documents for individual sites. Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, 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. 3 years’ of relevant experience working in the regulatory department in Argentina. Local and regional committees – Initial submission, Amendments, Response to Pending Issues. ANMAT and CCIS – Initial submission (EFCA1), list and calculation of medicines to be imported, Inclusion of centers (EFCA2), Amendments (EFCA3), Response to Pending Issues, IB Notification (EFCA4). ICF – Country and Site Specific Customization. Essential Documents Collection. TMF – Update Trackers and Check lists. Advanced level of English. Ability to work independently. LI-NRJ #LI-Hybrid 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 #J-18808-Ljbffr
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Sr. Site Activation Specialist in Argentina
hace 2 días
Buenos Aires, Argentina MVL Consulting A tiempo completoSr. Site Activation Specialist in Argentina IQVIA The Sr. Site Activation 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...
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Sr. Site Activation Specialist in Argentina
hace 5 días
Buenos Aires, Argentina IQVIA A tiempo completoThe **Sr. Site Activation 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. Developing professional...
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Sr. Site Activation Specialist
hace 2 semanas
Buenos Aires, Argentina Novasyte A tiempo completoSr Site Activation Specialist Home Based - Argentina Job Overview 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....
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Senior Site Activation Specialist — Start-Up
hace 2 días
Buenos Aires, Argentina MVL Consulting A tiempo completoA leading consulting firm in Buenos Aires is seeking a Sr. Site Activation Specialist. This role involves site activation activities per regulations, ensuring quality of deliverables, and acting as a SPOC for project teams. The ideal candidate will have a Bachelor's degree, at least three years of regulatory experience in Argentina, and proficiency in...
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Site Activation Lead: Regulatory
hace 2 días
Buenos Aires, Argentina SAP A tiempo completoA leading life sciences company in Buenos Aires is seeking a Sr. Site Activation Specialist to oversee site activation activities in accordance with regulations. The ideal candidate will have a Bachelor's degree in Life Science, 3 years of relevant regulatory experience in Argentina, and strong project management skills. Responsibilities include ensuring...
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Site Activation Specialist, External Commerce
hace 7 horas
Buenos Aires, Argentina AutoGrow (Petovera) A tiempo completoSite Activation Specialist, External Commerce IQVIA Site Activation Specialist for External Commerce (ComEx) - Homebased Essential Functions Responsible for importations and exportations in Chile Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. Perform start up and...
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Remote Site Activation Specialist, External Commerce
hace 7 horas
Buenos Aires, Argentina AutoGrow (Petovera) A tiempo completoA leading clinical research organization is seeking a Site Activation Specialist for External Commerce based in Buenos Aires, Argentina. The role involves managing import/export activities, adhering to SOPs, and performing site activation in compliance with regulations. Candidates should have clinical research experience, knowledge of external commerce in...
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Buenos Aires, Argentina IQVIA A tiempo completo**Essential Functions** - Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness,...
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Remote Contract Specialist – Site Activation
hace 2 semanas
Buenos Aires, Argentina IQVIA A tiempo completoA global clinical research provider is seeking a Contract Specialist to join their Global Site Activation team. The role involves contract negotiations with research sites, maintaining adherence to standard operating procedures, and providing local expertise during project planning. Candidates should have over 2 years of clinical research experience, a...
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Remote Regulatory
hace 4 días
Buenos Aires, Argentina Baker Hughes A tiempo completoA leading global organization is seeking a Regulatory & Start Up Specialist for a Home Based role in Buenos Aires, Argentina. The successful candidate will perform essential tasks related to Site Activation activities, ensuring compliance with regulations and project timelines. You will prepare and review regulatory documents, provide local expertise, and...
