Regulatory and Start Up Specialist
hace 6 días
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.Home Based role that require Spanish language fluency. 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 1-year clinical research experience within submissions. Equivalent combination of education, training and experience. 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 . At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes.
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Regulatory and Start Up Specialist
hace 6 días
Barcelona, España IQVIA A tiempo completoJob OverviewPerform 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.Home Based role that require Spanish language...
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Study Start Up Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoOverviewStudy Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and operational requirements into a predictable, high‑quality path to site activation.AccountabilitiesObtain and maintain essential documentation in...
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Study Start Up Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoOverviewEs posible que un gran número de candidatos se presenten a este puesto, así que asegúrese de enviar su CV y su solicitud lo antes posible.Study Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and...
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Study Start Up Manager
hace 4 días
Barcelona, España AstraZeneca A tiempo completoOverview Study Start Up Manager at AstraZeneca – based in Barcelona, Spain. Commitment: on‑site 3 days a week. Fluency in English required. Your role is to accelerate site activation, turning regulatory and operational requirements into a predictable, high‑quality path to site activation. Accountabilities Obtain and maintain essential documentation in...
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Clinical Study Start Up
hace 6 días
Barcelona, España ICON plc A tiempo completoStart Up Associate Home based Spain 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 Study Start Up Associate II to join...
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Clinical Study Start Up
hace 2 semanas
Barcelona, Barcelona, España ICON plc A tiempo completoStart Up Associate Home based SpainICON 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 developmentWe are currently seeking a Study Start Up Associate II to join our...
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Study Start Up Manager
hace 2 semanas
Barcelona, España AstraZeneca A tiempo completoIntroduction to rolePara ser considerado para una entrevista, por favor, asegúrese de que su solicitud se ajusta plenamente a las especificaciones del puesto que se encuentran a continuación.This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.Are you ready to accelerate site activation so...
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Study Start-up Team Lead-contracts and Finance
hace 2 semanas
Barcelona, España Novartis A tiempo completo*Role can be based in Madrid or Barcelona* The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to...
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Regulatory Specialist and Senior Specialist
hace 6 días
Barcelona, España Grouper Technology A tiempo completoRegulatory Affairs Specialist (Full-time, Permanent) Prinova is a leading global supplier of ingredients and premix manufacturing solutions for the food, beverage and nutrition industries. Prinova holds strategic stocks in 35+ centres around the world to ensure continuity of supply and has liquid and dry premix manufacturing facilities in the UK, China and...
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barcelona, España Barrington James A tiempo completoA leading IVD start-up in Barcelona is seeking a Junior QA/RA Specialist to support their Quality and Regulatory function. You'll contribute to the CE marking process for a Class C diagnostic device for kidney disease detection. Key responsibilities include implementing ISO 13485-compliant systems, managing technical documentation, and working closely with...
