Study Start Up Associate I
hace 1 semana
.As a Study Start Up Associate you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.The SSUA is responsible for leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and client standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.What you will be doing: Clinical Trial Site Activation Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.Register investigator sites and client stakeholders in client registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines.Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval (country dependent).Support investigators sites with local IRB workflow from preparation, submission through approval.Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed.Collaborate with the Study Team on the development and readiness of sites eISF when utilized and act as primary point of contact for the sites and manage the Site Operations/CRO monitor access to eISF prior to SIV.Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.Support & implement activities in Shared Investigator Platform to align with client strategy as it relates to the role.Coordinate translation of documents that are within scope with the preferred translation vendors
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Study Start Up Associate I
hace 4 semanas
Madrid, Madrid, España Icon A tiempo completoJob Title: Study Start Up Associate IIAt ICON, we are seeking a highly skilled and motivated Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative...
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Study Start Up Associate I
hace 4 semanas
Madrid, Madrid, España Icon A tiempo completoJob Title: Study Start Up Associate IIAt ICON, we are seeking a highly skilled and motivated Study Start Up Associate II to join our dynamic team. As a Study Start Up Associate II, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative...
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Study Start Up Associate
hace 6 meses
Madrid, España ICON plc A tiempo completoStudy Start Up Associate At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...
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Study Start Up Associate
hace 11 horas
28224 Pozuelo de Alarcón, Madrid provincia, España ICON Plc A tiempo completoStudy Start Up Associate II - Fluent Dutch Required 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 Study Start Up Associate / Regulatory...
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Study Start Up Associate I
hace 5 meses
Madrid, España ICON plc A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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Study Start Up Associate
hace 2 semanas
Madrid, España Icon Plc A tiempo completo.Study Start Up Associate II - Spain, Madrid 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. Study Start Up Associate / Regulatory Submissions -...
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Study Start-Up Specialist
hace 1 semana
Madrid, Madrid, España Icon Plc A tiempo completoStudy Start-Up Associate RoleThis challenging role involves leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.Key Responsibilities:Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics...
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Study Start Up Associate
hace 2 semanas
Madrid, España Icon Plc A tiempo completoStudy Start Up Associate II - Spain, MadridICON 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.Study Start Up Associate / Regulatory Submissions - Dutch...
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Study Start Up Associate
hace 2 semanas
Madrid, España Icon Plc A tiempo completoStudy Start Up Associate II - Spain, Madrid 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.Study Start Up Associate / Regulatory Submissions - Dutch...
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Manager, Study Start Up
hace 5 meses
Madrid, España Icon plc A tiempo completoManager, Study Start Up At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...
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Study Start Up Associate Ii
hace 5 meses
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 Intern
hace 4 meses
Madrid, España Allucent A tiempo completoThese customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...
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Study Start Up Manager
hace 4 meses
Madrid, España ICON plc A tiempo completoManager, Study Start Up At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...
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Manager, Study Start Up
hace 5 meses
Madrid, España ICON A tiempo completoAt ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery,...
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Associate Study Start-up Manager
hace 5 meses
Madrid, España Novasyte A tiempo completoAssociate Study Start-Up Manager IQVIA Biotech Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions: - Oversee the execution of Site Activation...
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Senior Manager, Study Start Up
hace 5 meses
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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Clinical Research Associate
hace 2 semanas
Madrid, Madrid, España Boston Scientific A tiempo completoJob Summary:As a Clinical Research Associate - Site Start-Up Specialist at Boston Scientific, you will play a critical role in supporting the Global Clinical Operations Center of Excellence. Your primary responsibility will be to conduct site start-up activities for clinical trials, ensuring compliance with regulatory requirements and company policies. This...
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Senior Study Start-Up Lead
hace 2 meses
Madrid, Madrid, España Caidya A tiempo completoJob Overview:The Senior Study Start-Up Lead will be responsible for managing the global and/or regional submission of clinical trial applications for studies executed by Caidya on behalf of clients. This role requires the ability to independently compile, review, and approve essential study documents and have a solid understanding of regulatory submission...
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Senior Study Start-Up Lead
hace 2 meses
Madrid, Madrid, España Caidya A tiempo completoJob Overview:The Senior Study Start-Up Lead will be responsible for managing the global and/or regional submission of clinical trial applications for studies executed by Caidya on behalf of clients. This role requires the ability to independently compile, review, and approve essential study documents and have a solid understanding of regulatory submission...
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Clinical Research Associate
hace 3 semanas
Madrid, Madrid, España Boston Scientific Gruppe A tiempo completoAbout this role:This Clinical Research Associate role supports the Global Clinical Operations Center of Excellence, conducting activities consistent with GCO's mission of building a world-class shared clinical technology, process innovation, and clinical operations team, in partnership with the company's divisions, through technology enablement, high-touch...