R-38 - Clinical Development And Affairs Manager Emea

hace 3 días


Madrid, España Ares Consultores A tiempo completo

Clinical Development and Affairs Manager EMEALocation: Germany, Spain, Netherlands, United KingdomWe are seeking a Clinical Development and Affairs Manager to enhance our EMEA Operating Model for Medical and Scientific Affairs.
This role focuses on supporting evidence generation studies, reports, and documentation to maintain regulatory-approved claims and meet market needs, with an emphasis on CE-IVDR requirements.
The position involves close collaboration with Medical and Scientific Affairs, Regulatory Affairs, and Clinical Affairs, and requires practical knowledge of regulatory requirements to manage and execute studies and reports effectively.What You Can Expect: You will be required to design studies to maintain claims in EMEA, focusing on CE-IVDR.Providing protocol development support for regional/local studies in line with regulatory standards.Collaboration with R&D, Regulatory Affairs, and Clinical Affairs.Bridging regional requirements with Hologic's global functions to ensure seamless communication and alignment, particularly for EU regulatory clearance and commercialization.You will be expected to maintain an understanding of ongoing clinical trials in the region.Stay updated on EU (CE-IVDR) and country-specific regulatory requirements (e.G., UKCA), clinical trial guidelines, industry standards, and ethical guidelines.Develop and maintain SOPs.What We Expect: Knowledge of clinical development processes, including study design, protocol development, and study monitoring.Familiarity with regulatory requirements (CE-IVDR, UKCA, ISO standards), QMS, and GCP guidelines.Expertise in in-vitro diagnostic technologies and proficiency in medical and regulatory terminology.Strong project management and problem-solving skills.Proficiency in data analysis and interpretation of clinical trial data.Effective cross-functional collaboration and communication abilities.Leadership skills for guiding global teams and managing risks.Integrity, attention to detail, resilience, and a commitment to innovation and continuous improvement.PhD in biological sciences preferred; experience in clinical pathology or clinical development within the IVD industry.What We Offer: We offer an exciting opportunity to join a dynamic team where you will drive impactful clinical studies while ensuring compliance with regulatory standards.
Our collaborative and innovative work environment provides opportunities for professional growth and the chance to contribute to significant advancements in healthcare.
We look forward to welcoming you to our team#J-18808-Ljbffr



  • Madrid, Madrid, España Boston Scientific Corporation A tiempo completo

    Company OverviewBoston Scientific Corporation is a leading medical technology company that aims to transform lives through innovative medical solutions. Our mission is to improve the health and well-being of patients around the world.Estimated Salary: €120,000 - €150,000 per yearJob DescriptionThe Senior Director of Clinical Affairs, EMEA RM, will be...


  • Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    Job Description:As a Clinical Content Development Manager at Syneos Health, you will be responsible for developing and managing clinical content across various projects and teams. This is a fantastic opportunity for experienced medical writers to join our Clinical and Corporate - Prod team and contribute to the creation of high-quality clinical content.Key...


  • Madrid, Madrid, España Boston Scientific Corporation A tiempo completo

    Job SummaryAs a Senior Director of Clinical Affairs, EMEA RM at Boston Scientific Corporation, you will be responsible for leading a dynamic team dedicated to professional education, Investigator-Sponsored Research (ISR), and collaborative trials within the EMEA region. This role requires a strategic leader with a deep understanding of clinical affairs and a...


  • Madrid, España Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Madrid, M, ES**Additional Locations**: Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Ireland-Galway; Italy-Milan; Netherlands-Kerkrade; Poland-Warsaw; United Kingdom-Hemel Hempstead**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific,...


  • Madrid, España Boston Scientific Corporation A tiempo completo

    .Work mode: HybridOnsite Location(s):Madrid, M, ESAdditional Locations: Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Ireland-Galway; Italy-Milan; Netherlands-Kerkrade; Poland-Warsaw; United Kingdom-Hemel HempsteadDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the...


  • Madrid, España Boston Scientific Corporation A tiempo completo

    Work mode: HybridOnsite Location(s):Madrid, M, ESAdditional Locations: Spain-Madrid; France-Île-de-France; Germany-Düsseldorf; Ireland-Galway; Italy-Milan; Netherlands-Kerkrade; Poland-Warsaw; United Kingdom-Hemel HempsteadDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the...


  • Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Company OverviewSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.About UsWe are an agile team driven to accelerate the delivery of therapies because we are passionate...


  • Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    **Company Overview**Syneos Health is a leading fully integrated biopharmaceutical solutions organization, built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.Our Clinical Development model puts the customer and patient at the center of everything we...


  • Madrid, España Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Madrid, FR**BOSTON SCIENTIFIC** Boston Scientific Boston Scientific is transforming lives through innovative medical solutions. In doing so, we are at the forefront of the medical technology industry and are constantly developing it further. At Boston Scientific, we want to give you the opportunity to use...

  • Lead Medical Writer

    hace 7 días


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Syneos Health is a leading provider of integrated biopharmaceutical solutions. Our team is built to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes.We are continuously looking for ways to simplify and streamline our work to make us easier to work with and for. Our Clinical Development model...


  • Madrid, Madrid, España Align Technology, Inc. A tiempo completo

    We are looking for a highly skilled Clinical Programs Manager EMEA to join our team at Align Technology, Inc.About the RoleThis is an exciting opportunity to lead clinical education programs for the GP channel across EMEA, promoting the adoption of Invisalign system, iTero intraoral scanner, and Align Digital solutions.The ideal candidate will have a deep...


  • Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    About Syneos HealthSyneos Health is a leading fully integrated biopharmaceutical solutions organization. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self...


  • Madrid, Madrid, España Align Technology, Inc. A tiempo completo

    About the OpportunityAt Align Technology, Inc., we are revolutionizing the orthodontic industry with innovative solutions. As a Clinical Education Manager for EMEA, you will play a crucial role in driving adoption of our systems, including Invisalign and iTero.ResponsibilitiesCreate and maintain clinical education pathways and engagement activities for...


  • Madrid, Madrid, España Esp Fortrea Development Sa A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Clinical Research Operations Manager to join our team at Fortrea Development SA. As a key member of our operations team, you will play a vital role in ensuring the successful execution of clinical trials across multiple therapeutic areas.Job DescriptionThe Senior Clinical Research Operations Manager will...


  • Madrid, España Johnson & Johnson A tiempo completo

    Global Clinical Operations (GCO) Position Title: CLINICAL RESEARCH MANAGER (Functional Manager II) **Position Summary**: The Clinical Research Manager (FM II) is accountable for strategic and operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s), including resource...


  • Madrid, Madrid, España Empresa Reconocida A tiempo completo

    Job OverviewIn this esteemed position at Empresa Reconocida, you will have the opportunity to drive clinical development and lead key projects within our restructured R&D organisation. Your mission will be to further strengthen our R&D capabilities and contribute to the preparation of oncology portfolio clinical development plans.Main...


  • Madrid, Madrid, España Syneos Health Commercial Solutions A tiempo completo

    About the OpportunityWe are excited to offer a challenging and rewarding opportunity for a Medical Science Liaison to join our team at Syneos Health Commercial Solutions. As a key member of our organization, you will be responsible for engaging with the healthcare/scientific community to advance clinical development programs.The primary focus of this role is...


  • Madrid, Madrid, España Esp Fortrea Development Sa A tiempo completo

    About Esp Fortrea Development SaAt Esp Fortrea Development Sa, we are a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions...


  • Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...


  • Madrid, Madrid, España Syneos Health Commercial Solutions A tiempo completo

    **About the RoleSyneos Health Commercial Solutions is a global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients.We are seeking an experienced Clinical Development Consultant to join our team. As a key member of our field medical team, you will partner with talented clinicians to advance clinical...