Study Initiation Specialist Lead

hace 3 semanas


Barcelona, Barcelona, España ICON A tiempo completo
About the Opportunity

We are currently seeking a Study Initiation Specialist Lead to join our dynamic team. As a Sr. Study Start Up Associate at ICON, 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.

Your Key Responsibilities:

  1. Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
  2. Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
  3. Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
  4. Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
  5. Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Skills and Qualifications:

  • Bachelor's degree in life sciences or a related field.
  • Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.
  • Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
  • Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
  • Fluency in English and Spanish.

Benefits and Compensation:

  • A competitive salary of $75,000 - $95,000 per year, depending on location and experience.
  • A range of benefits, including various annual leave entitlements, health insurance offerings, retirement planning options, and flexible country-specific optional benefits.

  • Study Start-Up Specialist

    hace 2 semanas


    Barcelona, Barcelona, España Engineeringuk A tiempo completo

    **About ICON plc**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.We are currently seeking a Study Start-Up Specialist to join our diverse and...


  • Barcelona, Barcelona, España Icon Plc A tiempo completo

    Senior Study Start Up Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, welcoming professionals to contribute to our mission shaping the future of clinical development. We seek a Senior Study Start Up Associate to join our diverse team. As a...


  • Barcelona, Barcelona, España ICON A tiempo completo

    Senior Study Operations AssociateICON is a world-leading healthcare intelligence and clinical research organization.We're seeking a Senior Study Operations Associate to join our diverse and dynamic team. As a Senior Study Operations Associate at ICON, you will play a key role in leading the initiation of clinical trials, ensuring compliance with regulatory...


  • Barcelona, Barcelona, España Ares Consultores A tiempo completo

    **About the Role:**Ares Consultores seeks a skilled Site Operations Specialist to join our team in Barcelona. This is an onsite role, requiring 3 days of office work and 2 days of remote work.As a Site Operations Specialist, you will be responsible for managing clinical studies at assigned sites and serving as the primary contact with study sites. You will...


  • Barcelona, Barcelona, España ICON A tiempo completo

    Regulatory Affairs SpecialistICON plc is a world-leading healthcare intelligence and clinical research organization.We are currently seeking a Regulatory Affairs Specialist to join our dynamic team. As a Regulatory Affairs Specialist at ICON, you will play a crucial role in ensuring compliance with regulatory requirements for clinical trials.Main...


  • Barcelona, Barcelona, España Tfs Healthscience A tiempo completo

    About this Role at TFS HealthScienceTFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and functional service (FSP) solutions.Key ResponsibilitiesThe...


  • Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo

    About BayerBayer (Schweiz) Ag is a leading global healthcare company committed to developing innovative products that improve human health and quality of life.As a Clinical Study Excellence Scientist at Bayer, you will play a crucial role in ensuring the safety of study participants, the quality of data, and the success of our development projects.Job...


  • Barcelona, Barcelona, España Icon A tiempo completo

    At ICON plc, a world-leading healthcare intelligence and clinical research organization, we are seeking a highly skilled Clinical Trial Operations Specialist to join our dynamic team.We offer a competitive salary of $90,000 - $110,000 per year, depending on experience.About the RoleThis is a key position in our Clinical Trials group, responsible for leading...


  • Barcelona, Barcelona, España Icon Plc A tiempo completo

    Job Description: We are seeking a highly skilled Clinical Trial Operations Specialist to join our team at ICON Plc, a world-leading healthcare intelligence and clinical research organization.About Us:We foster an inclusive environment driving innovation and excellence, and we welcome you to be a part of it. Our mission is to shape the future of clinical...


  • Barcelona, Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    Clinical Trial Assistant Job DescriptionThis is a challenging opportunity for a skilled Clinical Trial Assistant to join Vall d'Hebron Institut de Recerca's Academic Research Organization Unit.Main Responsibilities:Create and collect all necessary documentation for obtaining the approval of a clinical studySupport to the CRA in preparing site initiation...

  • Lead Medical Writer

    hace 4 semanas


    Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    Company OverviewSyneos Health, Inc. is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. Our integrated approach brings the customer and patient to the forefront of our work, driving innovation and collaboration to achieve goals.About the RoleThis Lead Medical Writer position requires an experienced professional...


  • Barcelona, Barcelona, España Red A tiempo completo

    Red has an exciting opportunity for a highly skilled SAP SD Lead specialist to join one of its global clients on a short-term project. This role requires a professional with extensive knowledge of SAP SD and leadership skills to start as soon as possible.Job OverviewThis contract position involves working as an SAP SD Lead in a hybrid environment, combining...


  • Barcelona, Barcelona, España Cea Study Abroad A tiempo completo

    About Cea Study Abroad">At Cea Study Abroad, we believe that studying and interning abroad is a transformative experience that goes beyond academics. By immersing oneself in a new culture and community, students gain valuable skills and perspectives that can shape their future. That's why we're committed to providing unparalleled academic, professional, and...


  • Barcelona, Barcelona, España Icon Plc A tiempo completo

    About ICON PlcICON 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 talented professionals to join us on our mission to shape the future of clinical development.Job Description:We are currently seeking a Senior Study Start Up...


  • Barcelona, Barcelona, España ICON A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Associate Manager to lead the initiation of clinical trials and ensure compliance with regulatory requirements. The ideal candidate will have a strong understanding of regulatory guidelines and excellent organizational skills.About the Role:Lead the preparation and submission of regulatory...


  • Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completo

    **About Syneos Health, Inc.**Syneos Health is a leading global contract research organization (CRO) that provides clinical development services to the pharmaceutical, biotechnology, and medical device industries.We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and...


  • Barcelona, Barcelona, España TFS HealthScience A tiempo completo

    About TFS HealthScienceTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.We are seeking a highly skilled...


  • Barcelona, Barcelona, España Cmed Group Ltd A tiempo completo

    A compelling opportunity awaits a highly skilled Lead Clinical Content Specialist to join Cmed Group Ltd in the UK or EU. As a key member of our Medical Writing team, you will be responsible for coordinating and managing medical writing tasks with precision and attention to detail.Key Responsibilities:Coordinate and manage medical writing tasks, ensuring...


  • Barcelona, Barcelona, España Pharmiweb A tiempo completo

    About the RoleWe are seeking a seasoned Clinical Operations Manager to oversee and coordinate clinical monitoring activities from site selection to study close-out. This is a hands-on position requiring a strong background in CRA activities and a proven track record of managing trials across multiple phases (Phase I-IV).Key ResponsibilitiesLead clinical...


  • Barcelona, Barcelona, España Icon A tiempo completo

    About ICONICON 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.Job Summary:We are currently seeking a Clinical Research Coordinator - Regulatory Affairs...