Clinical Study Lead – Diagnostics

hace 4 semanas


Madrid, España Qiagen Gruppe A tiempo completo

.At the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare. Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.Join us. At QIAGEN, you make a difference every day.Position Description The Clinical Study Lead (CSL) serves as a key member of the project core team with the goal to significantly contribute towards efficient launch of new or improved products. This role will focus on Oncology and Biopharma Companion Diagnostics product areas.Key responsibilities:Study design, strategy, planning (timeline, required resources and budget) for QIAGEN sponsored clinical studies.Coordinating clinical activities with stakeholders internally and externally and providing regular status reports. This role requires close collaboration and coordination of activities with pharma partners and test labs for conducting companion diagnostic clinical performance studies.Development and execution of all study associated documentation including protocols, investigator brochure, informed consent, contracts, and reports, in compliance with relevant regulations, guidelines and SOPs.Manage and track clinical studies, ensuring study completion in a timely manner within budget, escalating potential issues, setting up and coordinating internal and external communications and meetings for correction, troubleshooting, and prevention planning.Identify, enlist and choose sites, and coordinate site management activities including ensuring study site preparation, equipment, and training are compliant to the clinical protocol and organization's SOPs.Coordinate, supervise and train internal and external teams as required. Arrange and oversee site visits. Accountable for managing site auditing or QC visits where necessary to address or improve quality. Support during audits, e.G., BIMO, Pharma partner, FDA.Oversight of regulatory requirements for conducting clinical performance studies in the appropriate geographies (e.G., IVDR requirements for EU/EEA, FDA requirements for USA etc). Liaise with internal and external stakeholders for regulatory deliverables.Accountable for study close out procedures on study binders, datasets and study supplies working with CTAs, CRAs and Data/Statistics stakeholders for close-out documents and reviews.Author clinical study reports and study related submission documents to regulatory authorities, IRBs and local agencies in line with their requirements and respond to queries



  • Madrid, España Qiagen Gruppe A tiempo completo

    At the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare. Our most valuable asset are our employees – more than 6000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams...


  • Madrid, España Qiagen Gruppe A tiempo completo

    At the heart of QIAGEN's business is a vision to make improvements in life possible.We are on an exciting mission to make a real difference in science and healthcare.Our most valuable asset are our employees – more than 6000 in over 35 locations around the world.Our ambition is to ensure we have outstanding and passionate people working in the best teams...

  • Clinical Study Lead

    hace 3 días


    Madrid, Madrid, España QIAGEN Gruppe A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Study Lead to join our team at QIAGEN Gruppe. As a key member of our project core team, you will play a crucial role in the efficient launch of new or improved products in the Oncology and Biopharma Companion Diagnostics product areas.Key ResponsibilitiesStudy Design and Strategy: Develop and implement...

  • Clinical Study Lead

    hace 3 días


    Madrid, Madrid, España QIAGEN Gruppe A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Study Lead to join our team at QIAGEN Gruppe. As a key member of our project core team, you will play a crucial role in the efficient launch of new or improved products in the Oncology and Biopharma Companion Diagnostics product areas.Key ResponsibilitiesStudy Design and Strategy: Develop and implement...


  • Madrid, Madrid, España Abbvie A tiempo completo

    **Job Summary**At AbbVie, we are committed to discovering and delivering innovative medicines and solutions that solve serious health issues. As a Clinical Study Manager, you will play a critical role in bringing clinical studies to life through the execution of Phase 1-4 clinical research studies.**Key Responsibilities:**Develop and execute clinical...

  • Clinical Study Manager

    hace 2 días


    Madrid, Madrid, España Abbvie A tiempo completo

    **Job Summary**At AbbVie, we are committed to discovering and delivering innovative medicines and solutions that solve serious health issues. As a Clinical Study Manager, you will play a critical role in bringing clinical studies to life through the execution of Phase 1-4 clinical research studies.**Key Responsibilities:**Develop and execute clinical...

  • Clinical Study Manager

    hace 3 días


    Madrid, Madrid, España AbbVie A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Study Manager to join our team at AbbVie. As a Clinical Study Manager, you will be responsible for connecting science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies.Key ResponsibilitiesExecute clinical studies in compliance with...

  • Clinical Study Manager

    hace 3 días


    Madrid, Madrid, España AbbVie A tiempo completo

    About the RoleWe are seeking a highly skilled Clinical Study Manager to join our team at AbbVie. As a Clinical Study Manager, you will be responsible for connecting science and operations to bring clinical studies to life through the execution of one or more Phase 1-4 clinical research studies.Key ResponsibilitiesExecute clinical studies in compliance with...


  • Madrid, España Emprego ES A tiempo completo

    REGIONAL CLINICAL STUDY MANAGER **Datos**: **Datos Adicionales**: INVESTIGACIÓN Y DESARROLLO (I+D). IMPRESCINDIBLE CERTIFICADO DE DISCAPACIDAD IGUAL O SUPERIOR A 33%, y valorable EXPERIENCIA demostrable, para realizar en la empresa, entre otras, las FUNCIONES de: Accountable for regional study delivery with appropriate inspection readiness quality, within...


  • Madrid, Madrid, España Caidya A tiempo completo

    **Job 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, as well as have a solid understanding of regulatory...


  • Madrid, Madrid, España Caidya A tiempo completo

    **Job 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, as well as have a solid understanding of regulatory...


  • Madrid, España Mabxience A tiempo completo

    Supervise and guarantee the proper execution and follow the clinical trials under their responsibility delegated to CROs, in the established time and quality.Responsibilities: Manage the clinical trial plan under their responsibility, communicating any deviation on times to the Medical Director and participating in the elaboration of contingency plans and...


  • Madrid, España Mabxience A tiempo completo

    Overview: Supervise and guarantee the proper execution and follow the clinical trials under their responsibility delegated to CROs, in the established time and quality. **Responsibilities**: - Manage the clinical trial plan under their responsibility, communicating any deviation on times to the Medical Director and participating in the elaboration of...


  • Madrid, España Mabxience A tiempo completo

    Supervise and guarantee the proper execution and follow the clinical trials under their responsibility delegated to CROs, in the established time and quality.Responsibilities: Manage the clinical trial plan under their responsibility, communicating any deviation on times to the Medical Director and participating in the elaboration of contingency plans and...


  • Madrid, Madrid, España Abbvie A tiempo completo

    Job DescriptionJob Summary: We are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and...


  • Madrid, Madrid, España Abbvie A tiempo completo

    Job DescriptionJob Summary: We are seeking a highly skilled and experienced Study Management Associate III to join our dynamic and centralized study management team at AbbVie. As a key member of the study team, you will be responsible for the execution of our global clinical trials and will work closely with cross-functional partners to plan, execute, and...

  • Clinical Team Lead Ii

    hace 3 semanas


    Madrid, España Rho A tiempo completo

    .OverviewJoin us in redefining what it means to work for a CRO. Working at Rho, you'll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity's biggest challenges.At Rho, we're committed to you just as you're committed to us. You'll have the opportunity to...


  • Madrid, España AstraZeneca A tiempo completo

    The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. CSAs might have different internal titles based on the...

  • Clinical Study Manager

    hace 2 días


    Madrid, Madrid, España Mabxience A tiempo completo

    Job SummaryMabxience is seeking a highly skilled Clinical Study Coordinator to join our team. As a key member of our clinical operations department, you will be responsible for ensuring the successful execution of clinical trials.Key ResponsibilitiesManage clinical trial plans, communicating any deviations to the Medical Director and participating in the...

  • Clinical Study Manager

    hace 23 horas


    Madrid, Madrid, España Mabxience A tiempo completo

    Job SummaryMabxience is seeking a highly skilled Clinical Study Coordinator to join our team. As a key member of our clinical operations department, you will be responsible for ensuring the successful execution of clinical trials.Key ResponsibilitiesManage clinical trial plans, communicating any deviations to the Medical Director and participating in the...