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Local Start-Up Senior Specialist
hace 4 días
.At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote) The Local Start-up Senior Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.In this role your key tasks will include:Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)Ensure planned dates are reliable and up to date in CTMS departments/study teamsFile documents in the (e)TMF for which they are the document ownerAssist other Study Start-up team members with filing documents in the (e)TMF for which they are document ownerAssist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local levelProvide relevant documents in compliance with local regulationSupport review of technical, pre-clinical and clinical reports for regulatory submissionsInteract with regulatory authoritiesPrepare and compile answers for questions raised by the regulatory agencies and submit the answersRegularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriateSupport Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as neededPrepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local levelAssist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislationInteract with IEC/IRBPrepare and compile answers for questions raised by the IEC/IRB and submit the answersRegularly check for updates on regulations, guidelines, and procedures
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Local Start-Up Senior Specialist
hace 4 días
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)!The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 4 días
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)!The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 2 semanas
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 4 días
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 1 semana
Madrid, Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote) The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 5 días
Madrid, España Allucent A tiempo completoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Senior Specialist
hace 3 semanas
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Senior Specialist (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Senior Specialist (LSUS)...
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Local Start-Up Specialist I/Ii
hace 4 días
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)!The Local Start-up Specialist (LSUS) coordinates and...
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Local Start-Up Specialist I/Ii
hace 15 horas
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)!The Local Start-up Specialist (LSUS) coordinates and...
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Local Start-Up Specialist I/II
hace 1 semana
Madrid, Madrid, España Allucent A tiempo completoAt AllucentTM, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote) The Local Start-up Specialist (LSUS) coordinates and...
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Local Start-Up Specialist I/II
hace 2 días
Madrid, España Allucent A tiempo completoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates...
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Local Start-Up Specialist I/II
hace 1 mes
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and...
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Local Start-Up Specialist I/II
hace 1 mes
Madrid, España Allucent A tiempo completoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates...
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Local Start-Up Specialist I/II
hace 4 semanas
Madrid, España Allucent A tiempo completoAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates...
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Local Start-Up Specialist I/II
hace 4 semanas
Madrid, España Allucent A tiempo completoAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Local Start Up Specialist I/II (LSUS) to join our A-team (hybrid*/remote)! The Local Start-up Specialist (LSUS) coordinates and...
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Senior Manager, Study Start Up
hace 1 semana
Madrid, España ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Senior Manager, Study Start Up
hace 1 semana
Madrid, Madrid, España ICON plc A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...
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Study Start-up Cra
hace 3 semanas
Madrid, España Novartis A tiempo completoThe Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs. Proactive site preparation and early identification of real site...
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Cta Start Up
hace 1 semana
Madrid, España ICON A tiempo completoICON 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. **What you will be doing**: - Transversal collaboration with each of the teams’ members within...
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Study Start-Up CRA
hace 1 semana
Madrid, Madrid, España Novartis A tiempo completoJob Description**Please note this role can be based remotely from locations across SpainThe Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local...