Start Up Lead/Senior Start Up Lead
hace 1 mes
.Start up Lead/Senior Start up Lead - Clinical Trial Services Remote RomaniaJob Type: regular full-timeDivision: Precision for MedicineBusiness Unit: Clinical SolutionsRequisition Number: 4478Precision for Medicine (CRO) is hiring an experienced Start up Lead/Senior Start up Lead who has a passion for site start up to join our team. Candidates can be based in the following countries: Spain, UK, Hungary, Slovakia, Serbia, Romania, or Poland.Position Summary:The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. The SU Lead will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs, or others) supporting site start-up activities, Trainer for less-experienced staff, and may be identified as Owner of country-specific tools and guidance documents to increase knowledge share of country-specific site start-up activities.Essential functions of the job include but are not limited to:Manage the site start-up process through development of an activation readiness strategy to enable oversight of site start-up delivery.Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start-up activities to allow on-time activation.Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start-up.Partner closely with Functional Leaders and Site Start-up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real-time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.Responsible for coordinating translations for documents required for submissions.Maintain communication with other key functions participating in country start-up, i.E., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project-specific status and deliverables.Act as SME for collection and maintenance of site-level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts, and budget negotiation requirements that may be in place as well as other start-up requirements for assigned country
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Start Up Lead/Senior Start Up Lead
hace 2 semanas
Madrid, Madrid, España Precision Medicine Group, Llc. A tiempo completo**Job Summary**The Precision Medicine Group, LLC. is seeking an experienced Start Up Lead/Senior Start Up Lead to join our team. This role is responsible for the execution of site start-up activities and strategy planning, including the management and coordination of critical path planning, IRB/EC and CA/MoH submissions, and delivery of quality IMP release...
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Start Up Lead/Senior Start Up Lead
hace 2 semanas
Madrid, Madrid, España Precision Medicine Group, Llc. A tiempo completo**Job Summary**The Precision Medicine Group, LLC. is seeking an experienced Start Up Lead/Senior Start Up Lead to join our team. This role is responsible for the execution of site start-up activities and strategy planning, including the management and coordination of critical path planning, IRB/EC and CA/MoH submissions, and delivery of quality IMP release...
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X-063 Start Up Lead/Senior Start Up Leadnew
hace 1 mes
Madrid, España Precision Medicine Group A tiempo completo.Precision for Medicine (CRO) is hiring an experienced Start Up Lead/Senior Start Up Lead who has a passion for site start up to join our team. Candidates can be based in the following countries: Spain, UK, Hungary, Slovakia, Serbia, or Poland.Position Summary: The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the...
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[X-063] Start Up Lead/Senior Start Up Leadnew
hace 4 semanas
Madrid, España Precision Medicine Group A tiempo completoPrecision for Medicine (CRO) is hiring an experienced Start Up Lead/Senior Start Up Lead who has a passion for site start up to join our team. Candidates can be based in the following countries: Spain, UK, Hungary, Slovakia, Serbia, or Poland.Position Summary: The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the...
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Senior Study Start-Up Lead
hace 2 semanas
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 semanas
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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Study Start-up Cra
hace 4 meses
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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Project Manager Start Up
hace 4 meses
Madrid, España Labcorp A tiempo completo**Project Manager Start Up, EMEA, Remote** Helping our clients make their clinical trials a success by orchestrating the efforts of top-talented Clinical Research Teams. As **Project Manager Start Up** your principal responsibility is to oversee and manage the start-up through maintenance phase of domestic and/or international clinical trials. This...
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Global Clinical Start-up Manager Spain
hace 1 semana
Madrid, Madrid, España Resourcing Life Science A tiempo completoCompany OverviewOur client is a leading Contract Research Organization (CRO) providing comprehensive solutions for pharmaceutical and biotech companies worldwide. They offer a full-service approach encompassing clinical and non-clinical development, peri-approval, and market access.Job SummaryWe are seeking a highly experienced Clinical Start-up Manager to...
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Global Clinical Start-up Manager Spain
hace 1 semana
Madrid, Madrid, España Resourcing Life Science A tiempo completoCompany OverviewOur client is a leading Contract Research Organization (CRO) providing comprehensive solutions for pharmaceutical and biotech companies worldwide. They offer a full-service approach encompassing clinical and non-clinical development, peri-approval, and market access.Job SummaryWe are seeking a highly experienced Clinical Start-up Manager to...
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Senior Study Start-up Lead
hace 4 meses
Madrid, España Caidya A tiempo completo**Job Title: Senior Study Start-Up Lead (SSUL)** **Job Location**: Madrid, Spain**Job Overview**: Job Duties and Responsibilities: - Act as a SSU lead for the assigned countries and regions, participating directly at kick-off meetings, sponsor calls, providing the client with procedural and legal guidance, and study updates and advice as how to respond to...
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Study Start Up Associate
hace 2 semanas
Madrid, Madrid, España Icon Plc A tiempo completoJob SummaryAt ICON Plc, we are seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a key member of our clinical trials team, 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 treatments and...
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Study Start Up Associate
hace 1 semana
Madrid, Madrid, España ICON A tiempo completoStudy Start Up Associate II RoleICON 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 be part of our mission to shape the future of clinical development.Key Responsibilities:Lead the preparation and submission of...
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Study Start Up Associate
hace 1 semana
Madrid, Madrid, España ICON A tiempo completoStudy Start Up Associate II RoleICON 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 be part of our mission to shape the future of clinical development.Key Responsibilities:Lead the preparation and submission of...
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Study Start Up Associate
hace 2 semanas
Madrid, Madrid, España Icon Plc A tiempo completoJob SummaryAt ICON Plc, we are seeking a highly skilled and experienced Study Start Up Associate II to join our dynamic team. As a key member of our clinical trials team, 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 treatments and...
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Global Clinical Start Up Manager
hace 2 semanas
Madrid, Madrid, España Resourcing Life Science A tiempo completo**Job Overview**As a Clinical Start Up Manager with Resourcing Life Science, you will lead cross-functional project teams globally for assigned studies in the start up phase. Your primary focus will be on ensuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.**Key Responsibilities**Monitor study...
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Global Clinical Start Up Manager
hace 2 semanas
Madrid, Madrid, España Resourcing Life Science A tiempo completo**Job Overview**As a Clinical Start Up Manager with Resourcing Life Science, you will lead cross-functional project teams globally for assigned studies in the start up phase. Your primary focus will be on ensuring adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.**Key Responsibilities**Monitor study...
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Manager, Study Start Up
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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Study Start Up Associate
hace 2 semanas
Madrid, Madrid, España ICON A tiempo completoJob Summary:ICON is seeking a highly skilled and experienced 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 treatments and therapies.Key...
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Study Start Up Associate
hace 2 semanas
Madrid, Madrid, España ICON A tiempo completoJob Summary:ICON is seeking a highly skilled and experienced 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 treatments and therapies.Key...