KU450 | Send Specialist

hace 2 semanas


Barcelona, España Icon A tiempo completo

.As Nonclinical SEND data associate - sponsor dedicated, you will provide technical expertise in the on-going development and maintenance of processes, initiatives and management of CDISC SEND data, in order to allow the non clinical submissions group to deliver on FDA regulatory requirements for non clinical data standards, as well as SEND data utilisation across the Sponsor,

to maximise the opportunities this presents for Industry.What you will be doing Provide support across nonclinical functional areas to promote and enforce the use of non clinical data standards.Maintain metadata libraries,as adapted from industry standards Review and assess the impact of newly released and updated data standards and guidance documents to incorporate into the sponsor's business practices, as applicable Communicate Sponsor's data requirements to external vendors.Interact with external vendor personnel regarding standardized data transfer specifications, as necessary.Responsibility for quality validation and management of non clinical datasets.Communicating resolutions and managing timelines with external partners Provide training to internal customers and team members as appropriate.Assist in warehousing and visualisation activities that utilise SEND data within Sponsor Provide effective scheduling assistance in the timely delivery of SEND data for submissions Support transformation of in-house data into CDISC SEND format, ensuring submission ready datasets are produced Maintaining an in-depth understanding of evolving CDISC SEND standards and other regulatory standards/guidance Proactively manage own workload within timelines provided for FDA submissions Good clear communication skills both with management and project teams You Are Knowledge of CDISC standards is essential.Understand ing of non clinical study designs, data and documentation (e..plan/protocol, study schedules, deviations, drafts and final reports) Knowledge of regulatory guidelines and industry standards (FDA, ICH/GLP, PhUSE) Experience in data process builds Experience of LIMS and SEND solution software Education: Bachelor's degree (B../B..) or equivalent in a scientific or related discipline.Experience: Three to Five years related experience in a scientific environment.An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above Benefits of Working in ICON.Our success depends on the knowledge, capabilities and quality of our people.That's why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs

#J-18808-Ljbffr
  • Send Specialist

    hace 1 semana


    Barcelona, España Icon Plc A tiempo completo

    To apply for this job please sign in or create an account below. must be different from email address, first name and last name Keep me signed in Marketing Communication We'd love to send you information about Jobs and Services from Evenbreak by email. Yes please. I'd like to receive emails about jobs and services from Evenbreak I'd like to receive emails...

  • Google Ad Specialist

    Encontrado en: beBee S ES - hace 3 semanas


    Barcelona, España The George A tiempo completo

    Volvemos a publicar este anuncio debido a un error del copywriter: se había equivocado escribiendo el correo de contacto. Entonces, ahora también buscamos un copywriter. ¡Únete a Nuestro Equipo! 🚀 Join Our Team at The George Barcelona: Google Ads Specialist Wanted! 🚀 ¿Eres maestr@ de Google Ads con pasión por el marketing digital y un ojo...


  • Barcelona, España Nido Montessori Barcelona A tiempo completo

    Name of Employer: Barcelona Montessori SchoolJob Title: Forest School specialist – Montessori assistantClosing Date: June 21th 2020Salary: from 1250 to 2000 euros neto per monthLocation: Barcelona, SpainHow to Apply: Send you curriculum and covering letter to ****** Description: Barcelona MONTESSORI SCHOOL is looking for L3 Forest School practitioner to...


  • Barcelona, España Nido Montessori Barcelona A tiempo completo

    Name of Employer: Barcelona Montessori School Job Title: Forest School specialist – Montessori assistant Closing Date: June 21th 2020 Salary: from 1250 to 2000 euros neto per month Location: Barcelona, Spain How to Apply: Send you curriculum and covering letter to ****** Job Description: Barcelona MONTESSORI SCHOOL is looking for L3 Forest School...

  • Accounts Payable Specialist

    Encontrado en: Whatjobs ES C2 - hace 1 semana


    Barcelona, España Mazars Group A tiempo completo

    As part of Mazars’ strategic move to create a centralized and multi-country delivery Center of Excellence (CoE) to serve clients across Europe with Outsourcing and Compliance services, we are hiring an Accounts Payable Specialist to join this strongly growing international team in Barcelona. This is an opportunity to contribute to a strategic project at...


  • Barcelona, España Mazars Group A tiempo completo

    As part of Mazars’ strategic move to create a centralized and multi-country delivery Center of Excellence (CoE) to serve clients across Europe with Outsourcing and Compliance services, we are hiring an Accounts Payable Specialist to join this strongly growing international team in Barcelona. This is an opportunity to contribute to a strategic project at...

  • Onboarding Specialist

    Encontrado en: Talent ES C2 - hace 2 días


    Barcelona, España SiteMinder A tiempo completo

    At SiteMinder we believe the individual contributions of our employees are what drive our success. That’s why we hire and encourage diverse teams that include and respect a variety of voices, identities, backgrounds, experiences and perspectives. Our diverse and inclusive culture enables our employees to bring their unique selves to work and be proud of...

  • Accounts Payable Specialist

    Encontrado en: Talent ES C2 - hace 2 semanas


    Barcelona, España Mazars Group A tiempo completo

    As part of Mazars’ strategic move to create a centralized and multi-country delivery Center of Excellence (CoE) to serve clients across Europe with Outsourcing and Compliance services, we are hiring an Accounts Payable Specialist to join this strongly growing international team in Barcelona. This is an opportunity to contribute to a strategic project at...

  • Imaging Specialist

    hace 2 días


    Barcelona, España Centre For Genomic Regulation A tiempo completo

    The Cent re for Genomic Regulation (CRG) is an international biomedical research institute of excellence, based in Barcelona, Spain, with more than 400 scientists from 44 countries. The CRG is composed by an interdisciplinary, motivated and creative scientific team which is supported both by a flexible and efficient administration and by high-end and...


  • Barcelona, España Siteminder Group A tiempo completo

    At SiteMinder we believe the individual contributions of our employees are what drive our success. That's why we hire and encourage diverse teams that include and respect a variety of voices, identities, backgrounds, experiences and perspectives. Our diverse and inclusive culture enables our employees to bring their unique selves to work and be proud of...

  • Customer Onboarding Specialist

    Encontrado en: Talent ES C2 - hace 1 semana


    Barcelona, España SiteMinder A tiempo completo

    At SiteMinder we believe the individual contributions of our employees are what drive our success. That’s why we hire and encourage diverse teams that include and respect a variety of voices, identities, backgrounds, experiences and perspectives. Our diverse and inclusive culture enables our employees to bring their unique selves to work and be proud of...

  • Ot Security Specialist

    hace 3 días


    Barcelona, España Ag Solution Nv A tiempo completo

    OT security is a specialized branch in Cybersecurity. Our specialists are passionate in finding the equilibrium in between securing industrial environments and ensuring excelling production performance and continuity. Following the industrial standards (and beyond) we provide our customers with state ofthe art assessments, architectural solutions, tools and...

  • Quality Assurance Specialist

    Encontrado en: beBee S ES - hace 3 semanas


    Barcelona, España Galderma A tiempo completo

    At Galderma we're unique and we embrace difference.Whether it's the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising and rewarding people for the contribution they make - working here isn't like anywhere else.At Galderma, we actively give our teams reasons to believe in...

  • Digital Solution Advisor Specialist

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España SAP A tiempo completo

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...


  • Barcelona, España Baxter International Inc. A tiempo completo

    This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost...

  • Client Service Specialist for Online Payments

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España Blu Selection A tiempo completo

    Are you a number enthusiast with an interest in the financial insurance world? Are you structured and organized and have an affinity for technology and the online payment industry? Become this organization's new Client Service specialist in Barcelona, a vibrant city with different cultures, excellent food and beautiful beaches! Your responsibilities and...

  • Renewal Specialist

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España SAP A tiempo completo

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...

  • Renewal Specialist

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España SAP A tiempo completo

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...

  • S4 Generalist Presales Senior Specialist

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España SAP A tiempo completo

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...

  • Digital Solution Advisor Senior Specialist

    Encontrado en: beBee S ES - hace 4 semanas


    Barcelona, España SAP A tiempo completo

    We help the world run better Our company culture is focused on helping our employees enable innovation by building breakthroughs together. How? We focus every day on building the foundation for tomorrow and creating a workplace that embraces differences, values flexibility, and is aligned to our purpose-driven and future-focused work. We offer a highly...