Trabajos sae en BarcelonaCrear alertas

Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

🏢 About Us: Chery Spain R&D Center Chery Spain R&D Center is Chery Automobile’s regional R&D Center in Europe and a key part of its global strategy. The center focuses on European adaptation and validation, plant technical support, localized component development, quality issue analysis, connected vehicle operations, and FL vehicle development, while continuously strengthening its capabilities in product definition, validation, technical coordination, and project support. With the capability to independently develop large FL models for global markets, it plays a vital role in Chery’s global R&D network and is committed to delivering competitive solutions for both European and international markets. About the Role Chery Europe is looking for a Vehicle Security Operations Engineer to join our Product Digitalization team in Barcelona. In this role, you will support the cybersecurity operations of connected vehicles, cloud platforms, and backend services across the European market. You will play a key role in monitoring, detecting, and responding to cybersecurity threats while contributing to the development of a robust Vehicle Security Operations Center (VSOC) capability. This is a unique opportunity to join one of the fastest-growing automotive groups and contribute to the future of connected mobility in Europe. Key Responsibilities Monitor cybersecurity events, anomalies, incidents, and potential threats affecting connected vehicle ecosystems. Investigate and respond to security alerts and incidents, supporting root cause analysis and remediation activities. Develop and optimize detection rules, security use cases, and monitoring capabilities. Support the continuous improvement of VSOC processes, automation, and incident response playbooks. Contribute to compliance activities related to ISO/SAE 21434 and UNECE R155/R156 requirements. Collaborate with engineering, product, quality, aftersales, and operations teams across Europe and headquarters. Ensure secure and compliant operation of connected vehicle services within the European market. What We're Looking For Bachelor's Degree in Computer Science, Telecommunications, Cybersecurity, or a related field. 3+ years of experience in Cybersecurity Operations, SOC, VSOC, Threat Detection, or Incident Response environments. Experience with SIEM, IDS, security monitoring, and incident management tools. Understanding of threat analysis, vulnerability management, and proactive threat hunting. Knowledge of connected vehicle cybersecurity or automotive cybersecurity is highly desirable. Familiarity with ISO/SAE 21434, UNECE R155, GDPR, or related cybersecurity frameworks is a plus. Strong problem-solving and stakeholder management skills. Ability to work in an international and cross-cultural environment. Nice to Have Automotive OEM or Tier 1 supplier experience. Connected vehicle or IoT security experience. Spanish language skills. Chinese language skills. Experience supporting international projects. Why Join Chery Europe? Be part of one of the world's fastest-growing automotive manufacturers. Work on cutting-edge connected vehicle technologies. Join an international and multicultural environment. Contribute directly to the cybersecurity of next-generation vehicles in Europe. 📩 If you're passionate about automotive cybersecurity and want to shape the future of connected mobility, we'd love to hear from you. We hereby inform you that O&J Europe Business Corporation S.L., a company with its registered office at Parque Empresarial Arboretum, Avda. de la Fama No. 1, Cornellà de Llobregat, Barcelona 08940, Spain, and Tax Identification Number (CIF) B22849103 (hereinafter, the “Company”), will process your personal data on the basis of the pre-contractual relationship existing between you and the Company for the purpose of managing your job application. Your personal data may be disclosed to Chery Automobile Co., Ltd. (the Group’s parent company), located in China, for the purpose of carrying out the recruitment process for which you have voluntarily submitted your application. In accordance with the General Data Protection Regulation (GDPR), we inform you that the Personal Information Protection Law of the People’s Republic of China (PIPL) may differ from the GDPR in certain respects. Nevertheless, the Company implements all safeguards required under the GDPR, including, where applicable, the execution of Standard Contractual Clauses (SCCs). Your personal data will be retained for a period of two (2) years and will be securely deleted once this period has elapsed. Should you have any questions regarding your personal data, or if you wish to exercise your rights of access, rectification, erasure, restriction of processing, or objection at any time, you may contact us at the following email address: . Finally, please be informed that you have the right to lodge a complaint with the Spanish Data Protection Agency (AEPD) if you believe that a breach of data protection legislation has occurred in relation to the processing of your personal data.

Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Chery Spain R&D Center is Chery Automobile’s regional R&D Center in Europe and a key part of its global strategy. The center focuses on European adaptation and validation, plant technical support, localized component development, quality issue analysis, connected vehicle operations, and FL vehicle development, while continuously strengthening its capabilities in product definition, validation, technical coordination, and project support. With the capability to independently develop large FL models for global markets, it plays a vital role in Chery’s global R&D network and is committed to delivering competitive solutions for both European and international markets. Chery Europe is looking for a Vehicle Security Operations Engineer to join our Product Digitalization team in Barcelona. In this role, you will support the cybersecurity operations of connected vehicles, cloud platforms, and backend services across the European market. You will play a key role in monitoring, detecting, and responding to cybersecurity threats while contributing to the development of a robust Vehicle Security Operations Center (VSOC) capability. This is a unique opportunity to join one of the fastest-growing automotive groups and contribute to the future of connected mobility in Europe. Monitor cybersecurity events, anomalies, incidents, and potential threats affecting connected vehicle ecosystems. Investigate and respond to security alerts and incidents, supporting root cause analysis and remediation activities. Develop and optimize detection rules, security use cases, and monitoring capabilities. Support the continuous improvement of VSOC processes, automation, and incident response playbooks. Contribute to compliance activities related to ISO/SAE 21434 and UNECE R155/R156 requirements. Collaborate with engineering, product, quality, aftersales, and operations teams across Europe and headquarters. Ensure secure and compliant operation of connected vehicle services within the European market. Bachelor’s Degree in Computer Science, Telecommunications, Cybersecurity, or a related field. 3+ years of experience in Cybersecurity Operations, SOC, VSOC, Threat Detection, or Incident Response environments. Experience with SIEM, IDS, security monitoring, and incident management tools. Understanding of threat analysis, vulnerability management, and proactive threat hunting. Knowledge of connected vehicle cybersecurity or automotive cybersecurity is highly desirable. Familiarity with ISO/SAE 21434, UNECE R155, GDPR, or related cybersecurity frameworks is a plus. Strong problem-solving and stakeholder management skills. Ability to work in an international and cross-cultural environment. Automotive OEM or Tier 1 supplier experience. Connected vehicle or IoT security experience. Experience supporting international projects. Be part of one of the world’s fastest-growing automotive manufacturers. Work on cutting-edge connected vehicle technologies. Join an international and multicultural environment. Contribute directly to the cybersecurity of next-generation vehicles in Europe. We hereby inform you that O&J Europe Business Corporation S.L., a company with its registered office at Parque Empresarial Arboretum, Avda. de la Fama No. 1, Cornellá de Llobregat, Barcelona 08940, Spain, and Tax Identification Number (CIF) B22849103 (hereinafter, the “Company”), will process your personal data on the basis of the pre-contractual relationship existing between you and the Company for the purpose of managing your job application. Your personal data may be disclosed to Chery Automobile Co., Ltd. (the Group’s parent company), located in China, for the purpose of carrying out the recruitment process for which you have voluntarily submitted your application. In accordance with the General Data Protection Regulation (GDPR), we inform you that the Personal Information Protection Law of the People’s Republic of China (PIPL) may differ from the GDPR in certain respects. Nevertheless, the Company implements all safeguards required under the GDPR, including, where applicable, the execution of Standard Contractual Clauses (SCCs). Your personal data will be retained for a period of two (2) years and will be securely deleted once this period has elapsed. Should you have any questions regarding your personal data, or if you wish to exercise your rights of access, rectification, erasure, restriction of processing, or objection at any time, you may contact us at the following email address: dpo@omodaautoeub.com. Finally, please be informed that you have the right to lodge a complaint with the Spanish Data Protection Agency (AEPD) if you believe that a breach of data protection legislation has occurred in relation to the processing of your personal data. #J-18808-Ljbffr

Overview In this role you will serve as a global medical advisor and scientific expert across IQVIA divisions, guiding medical and scientific aspects of trials and business development. You will support investigators and project teams, review protocols and reports, and provide therapeutic area training. You’ll be involved in safety reviews, pharmacovigilance collaborations, and have 24/7 availability for urgent protocol questions, with regular travel. This is a high-impact position shaping clinical programs and patient outcomes within a leading CRO environment. Responsabilidades • Act as Global Medical Advisor on assigned projects and provide strategic medical guidance to project leaders, • Review protocols, IDBs, CRFs and CSR/patient narratives for medical accuracy and safety, • Provide therapeutic area training to project clinical teams and present at Investigator Meetings, • Review and clarify trial-related Adverse Events; participate in SAE case reviews with Pharmacovigilance, • Support AOSE analyses and collaborate with Pharmacovigilance on safety signal assessment, • Attend kickoff, weekly team, and client meetings; respond 24/7 to urgent protocol questions, • Travel 15-20% as needed, • Maintain up-to-date knowledge of scientific, clinical, regulatory, and competitive landscapes in applicable therapeutic areas Requisitos principales, • MD in Medicine with medical license appropriate to residence, • minimum 5 years of clinical medicine experience plus clinical trials experience (investigator or within Pharma/CRO/Biotech), • Board Certified, • experience or knowledge in Phase I or early clinical development, • Fluent English with extensive communication skills, • Knowledge of federal and local clinical research regulations and guidelines, • ability to work across diverse teams and provide medical leadership, • strong communication skills, • cross-functional collaboration, • problem-solving, • medical monitoring and safety review, • pharmacovigilance collaboration, • medical review of IDB/CRF/CSR

En Expleo acompañamos a las organizaciones en su transformación digital, impulsando la innovación, la calidad y la ciberseguridad en sectores industriales y críticos. Apostamos por el talento, el desarrollo profesional y los proyectos con impacto real. Actualmente estamos buscando un/a Cybersecurity Advisor con sólida experiencia en entornos ferroviarios, aeronáuticos, industriales y/o automoción. Liderar la estrategia y ejecución de ciberseguridad OT en entornos críticos, asegurando el cumplimiento normativo europeo y aportando valor tanto técnico como estratégico en proyectos ferroviarios, industriales, aeronáuticos y de automoción. El rol combina expertise técnico, conocimiento normativo, liderazgo de equipos y relación con cliente, con especial foco en entornos críticos (railway signalling, SCADA, sistemas industriales y manufacturing). • Definir e implementar estrategias de ciberseguridad en entornos OT, • Realizar análisis de riesgos, auditorías técnicas y evaluaciones de madurez., • Diseño de arquitecturas seguras para sistemas industriales y ferroviarios., • Integración de medidas de ciberseguridad en el ciclo de vida de sistemas críticos., • Experiencia en ciberseguridad bajo normativa europea, especialmente en el marco del Cyber Resilience Act (CRA)., • Participación en proyectos de consultoría y adecuación al CRA, incluyendo:, • Análisis de impacto regulatorio, • Evaluación de cumplimiento (gap analysis), • Definición de planes de adaptación, • Experiencia en auditorías de ciberseguridad en entornos OT/IT alineadas con normativa europea., • Revisión de controles de seguridad en productos, sistemas y servicios digitales., • Evaluación de cumplimiento de requisitos de:, • Seguridad por diseño (security by design), • Gestión de vulnerabilidades, • Actualizaciones y ciclo de vida seguro, • Coordinación y seguimiento de auditorías internas y externas., • Asesoramiento a clientes en la implantación de requisitos del CRA., • Definición de políticas, procesos y controles de ciberseguridad., • Acompañamiento en procesos de certificación y cumplimiento regulatorio., • Integración con otras normativas europeas relevantes:, • NIS2 Directive, • IEC 62443 (industrial), • ISO 27001, • Desarrollo de políticas y procedimientos de ciberseguridad OT., • Gestión de riesgos y continuidad de negocio., • Reporting ejecutivo y cuadros de mando., • Liderar equipos de consultores OT (formación, mentoring y crecimiento)., • Definir metodologías y marcos de trabajo internos., • Gestión de proyectos y relación directa con clientes (CISO, CTO, ingeniería)., • Apoyo en preventa y desarrollo de negocio., • Aplicación de normativas y estándares ferroviarios:, • IEC 62443, • CENELEC, • TS 50701 (Cybersecurity en Railway), • Participación en procesos de Common Safety Method (CSM-RA)., • Coordinación con organismos evaluadores., • Interacción con organismos de evaluación independiente:, • Liderazgo en procesos de certificación y cumplimiento., • Aplicación de estándares:, • IEC 62443, • ISO/SAE 21434, • Seguridad en entornos de producción, fábricas inteligentes y OT convergente con IT., • Evaluación de proveedores y cadena de suministro., • Experiencia mínima de 8 años en ciberseguridad, con foco en entornos OT/industrial, ferroviario y/o automoción., • Experiencia demostrable en consultoría de ciberseguridad y cumplimiento normativo en entornos regulados., • Experiencia en la participación de proyectos de adecuación al Cyber Resilience Act (CRA)., • Revisión y validación de documentación técnica en el marco de certificación y autorización., • Capacidad de liderazgo, comunicación con cliente y visión estratégica., • Nivel alto de inglés. Valorable buen nivel de francés., • Experiencia en consultoría y aplicación de normativa ferroviaria, incluyendo:, • CENELEC, • TS 50701 (ciberseguridad ferroviaria), • Participación en proyectos ferroviarios asegurando el cumplimiento de requisitos de:, • Safety (RAMS), • Ciberseguridad, • Integración sistema–infraestructura, • Experiencia en coordinación con organismos y procesos regulatorios ferroviarios, como:, • European Union Agency for Railways (ERA), • National Safety Authority (NSA) En Expleo creemos en el crecimiento profesional y en un entorno donde las personas pueden desarrollar su máximo potencial. • Entorno multicultural, colaborativo, cercano y multidisciplinar., • Desarrollo profesional continuo con formación técnica, idiomas y habilidades. Te puedes formar con nuestra Expleo Academy., • Proyectos innovadores en un contexto internacional., • Plan de compensación flexible, beneficios sociales y salario competitivo., • Seguro médico, clubs internos, actividades afterwork, kit de bienvenida y más..., • 24 días laborables de vacaciones + 24 y 31 de diciembre. Con la antigüedad, aumentan! Somos una empresa que ofrece igualdad de oportunidades y aceptamos solicitudes de todas las personas debidamente cualificadas, independientemente de su raza, género, discapacidad, religión/creencia, orientación sexual o edad. #J-18808-Ljbffr

Responsibilities (a) Site management • Study site selection, initiation (SIV) and clinical monitoring., • Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience., • Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations., • Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP., • Track study recruitment to ensure recruitment target is achieved in all studies., • Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating., • Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study., • Assemble site specific EC submission dossier, and ensure submission to EC. Training • Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements., • Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements. Documentation • Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files., • Prepare/complete study records’ archiving according to protocol and sponsor requirements. (b) Drug Safety • Ensure safety information is disseminated to all sites according SOP and applicable regulations., • Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations. (c) Finance and Administration • Finalize budget and obtain signed contract from site, prior to site initiation visit., • Ensure Study Payment Schedule is executed and retain relevant documents/receipts. (d) Study Tools and system • Update and maintain Study tools/systems in a timely manner. 1. Qualifications 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major. 3.2 At least 8 year of CRA experience; 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures; 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Chery Europe is seeking a Vehicle Security Operations Engineer to join the Product Digitalization team in Barcelona. You will support cybersecurity operations for connected vehicles, cloud platforms, and backend services across Europe, helping monitor, detect, and respond to threats to build a robust VSOC capability. The role involves collaborating with engineering, product, quality, aftersales, and operations teams across Europe to ensure secure vehicle services and compliance with ISO/SAE #J-18808-Ljbffr

Overview In this role you safeguard patient safety by coordinating pharmacovigilance across clinical development and post-marketing activities. You will collaborate with global teams to ensure regulatory compliance and robust safety monitoring. You provide operational and medical input for trials, safety reports, and submissions, while leading safety planning and medical reviews. Your work drives risk assessment and data-driven decisions to protect patients and support product safety strategy. Responsabilidades • Provide operational and medical support to clinical trials, including SAE management, medical review, reconciliation, unblinding, and safety monitoring, • Lead preparation and medical input for aggregate safety reports (DSURs) and periodic regulatory submissions, • Review safety-related sections of clinical documents (protocol synopses, Data Management Plans, Safety Topics of Interest), • Act as medical lead for the development of Safety Reporting Plans, • Participate in clinical study team meetings, including CRO collaboration, • Support non-interventional studies, market research, and registries (ICSR management and safety monitoring), • Conduct post-marketing safety surveillance, including medical review of data, • Support the Patient Safety Director and EU QPPV in regulatory duties, • Contribute to Pharmacovigilance Quality Management System and implementation of procedures, • Perform safety database tasks and signal detection as medical writer or reviewer, • Review PSURs and Risk Management Plans Requisitos principales, • Medical science degree, • Postgraduate training in pharmacovigilance, clinical safety, or epidemiology (preferred), • Experience in pharmacovigilance or clinical safety in a corporate setting (valued), • Proficiency in safety databases, • Strong understanding of GVPs and regulatory frameworks, • Cross-functional collaboration, • Attention to detail, • Effective communication with internal teams and CROs, • Safety databases proficiency, • ICSR management, • DSUR and PSUR review

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description SummarySr CRA SpainJob DescriptionROLEThe Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Salary range: 55.000 - 65.000KEY RESPONSABILITIESProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.Ensures appropriate and timely investigator site visits.Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.Assists in development of study-specific Monitoring Plans and training presentations as required.Assists in set up/collection of site specific ethics documents and site contract negotiation as required.Provides monthly billing information to finance team as required.For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.Ensures integrity of CRF data through meticulous and thorough source document review and verification.Performs quality control and verification of documents collected at sites for eTMF/TMF.Conducts investigational product accountability.Reviews site regulatory binder for required documents.Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.Participates in internal, client/sponsor, scientific, and other meetings as required.Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.Proactively identifies site issues and develops problem-solving strategies for sites.Conducts audit preparation at study sites as needed.Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.Participates in internal, client/sponsor, scientific, and other meetings as required.Assists in CRA new hire training and onboarding.Performs CRA mentoring.Collaborates with development and maintenance of Clinical Trial Management System (CTMS).Manages and resolves conflicting priorities to deliver on commitments.Performs additional duties as assigned.DESIRED QUALIFICATION & EXPERIENCEUS: BS/BA from an undergraduate program (life sciences or related discipline preferred)US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experience with 1 year of management experienceEU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges US: Strong command of English, both written and verbal EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performedExcellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data captureSelf-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements Ability to establish and maintain positive relationships with Sponsor, Site and Project Team membersEU: Graduation in a scientific health field. EU: Adequate English LanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract TypeRegularSalary RangeThe final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. 55.000 - 65.000SummaryLocation: Barcelona-Remote; Europe-RemoteType: Full time

Overview In this role you will lead and oversee clinical trial monitoring as a senior CRA within Alira Health’s global Clinical team. You will work independently and with cross-functional partners to ensure protocol compliance, quality, and timely site visits across Spain and Europe. You will shape monitoring plans, mentor junior CRAs, and collaborate with sponsors to resolve site issues, driving project success and study timelines. This position offers exposure to international teams and a mission-driven, inclusive culture. Compensaciones / Beneficios • remote work, • international team, • competitive salary range 55k-70k, • full-time contract, • location flexibility (Barcelona-Remote; Europe-Remote), • professional development opportunities Responsabilidades, • Provide guidance and oversight to the CRA team to meet scope, SOPs, timelines, and budgets, • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed, • Coordinate with cross-functional departments to resolve monitoring-related issues, • Assist in development of monitoring plans and training materials, • Assist in ethics documents setup and site contract negotiation, • Provide monthly billing information to finance, • Manage study budget for monitoring stand-alone projects and act as sponsor referent, • Perform qualification, initiation, interim, and close-out visits both remotely and onsite, • Document monitoring visits with clear reports on problems, resolutions, and enrollment status, • Ensure data integrity through source document review and eTMF/TMF verification, • Conduct investigational product accountability and review regulatory binders, • Maintain site communication to ensure GCP compliance and address sponsor requests, • Comply with ICH GCP, FDA regulations, and SOPs; participate in required meetings, • Facilitate adverse event reporting and reconcile SAE with sources and CRFs, • Collaborate with CRAs, data management to resolve data discrepancies, • Identify site issues and develop problem-solving strategies, • Support CRA onboarding and mentoring; contribute to CTMS maintenance, • Manage conflicting priorities to deliver on commitments, • Perform additional duties as assigned Requisitos principales, • BS/BA in life sciences or related discipline (US), • 3 years in pharma/biotech/CRO with 2 years clinical monitoring and 1 year management experience (US), • EU: at least 2 years of clinical monitoring experience with capability to autonomously manage monitoring activities, • Strong knowledge of ICH GCP and regulatory requirements, • Excellent communication and interpersonal skills; customer service orientation, • Ability to travel and manage stress; professional and trustworthy, • English proficiency (US) or Local language proficiency (EU), • Graduation in a scientific health field (EU), • Adequate English (EU), • quality-focused, • highly organized and multi-tasking, • problem-solving and negotiation, • CTMS knowledge, • eTMF/TMF documentation and verification, • clinical trial databases and electronic data capture

Overview In this role you will lead and oversee clinical trial monitoring as a senior CRA within Alira Health’s global Clinical team. You will work independently and with cross-functional partners to ensure protocol compliance, quality, and timely site visits across Spain and Europe. You will shape monitoring plans, mentor junior CRAs, and collaborate with sponsors to resolve site issues, driving project success and study timelines. This position offers exposure to international teams and a mission-driven, inclusive culture. Compensaciones / Beneficios • remote work, • international team, • competitive salary range 55k-70k, • full-time contract, • location flexibility (Barcelona-Remote; Europe-Remote), • professional development opportunities Responsabilidades, • Provide guidance and oversight to the CRA team to meet scope, SOPs, timelines, and budgets, • Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed, • Coordinate with cross-functional departments to resolve monitoring-related issues, • Assist in development of monitoring plans and training materials, • Assist in ethics documents setup and site contract negotiation, • Provide monthly billing information to finance, • Manage study budget for monitoring stand-alone projects and act as sponsor referent, • Perform qualification, initiation, interim, and close-out visits both remotely and onsite, • Document monitoring visits with clear reports on problems, resolutions, and enrollment status, • Ensure data integrity through source document review and eTMF/TMF verification, • Conduct investigational product accountability and review regulatory binders, • Maintain site communication to ensure GCP compliance and address sponsor requests, • Comply with ICH GCP, FDA regulations, and SOPs; participate in required meetings, • Facilitate adverse event reporting and reconcile SAE with sources and CRFs, • Collaborate with CRAs, data management to resolve data discrepancies, • Identify site issues and develop problem-solving strategies, • Support CRA onboarding and mentoring; contribute to CTMS maintenance, • Manage conflicting priorities to deliver on commitments, • Perform additional duties as assigned Requisitos principales, • BS/BA in life sciences or related discipline (US), • 3 years in pharma/biotech/CRO with 2 years clinical monitoring and 1 year management experience (US), • EU: at least 2 years of clinical monitoring experience with capability to autonomously manage monitoring activities, • Strong knowledge of ICH GCP and regulatory requirements, • Excellent communication and interpersonal skills; customer service orientation, • Ability to travel and manage stress; professional and trustworthy, • English proficiency (US) or Local language proficiency (EU), • Graduation in a scientific health field (EU), • Adequate English (EU), • quality-focused, • highly organized and multi-tasking, • problem-solving and negotiation, • CTMS knowledge, • eTMF/TMF documentation and verification, • clinical trial databases and electronic data capture

Plimon - Regulatory B2B (Food, Cosmetics, F&F, Industrial) Ubicación: Granollers (Barcelona) A continuación se detalla todo lo que necesita saber sobre lo que implica esta oportunidad, así como lo que se espera de los solicitantes. ¿Quiénes somos? Plimon es una empresa de producción y distribución de materias primas para el sector alimentario, cosmético, químico y farmacéutico. Con un claro plan de negocio, en los últimos años se han conseguidos grandes crecimientos (de los 11M de facturación en 2019 a los 30M en 2025) y se espera seguir con esta senda en los próximos años. El proyecto está liderado por un equipo joven y dinámico. Las oficinas centrales están en Granollers y la planta de producción en Artesa de Lérida, donde se producen y formulan aceites vegetales y esenciales, y también se realiza un proceso de atomización (Spray Drying). ¿Qué harás? Estamos buscando un/a especialista "Regulatory B2B (Food, Cosmetics, F&F, Industrial)" para unirse a nuestro equipo. Algunas de las tareas a realizar son las siguientes: • Control de requisitos legales/regulatorios de los productos, • Definición y realización de fichas técnicas y especificaciones de producto, • Realización de fichas de seguridad de producto, • Soporte a la certificación de productos y sistemas de la empresa por parte de entidades externas, • Soporte en la gestión de incidencias y no conformidades, • Gestión de las solicitudes documentales de cliente junto al departamento comercial El candidato formará equipo con el Quality Manager, lo que le dará una visión completa del funcionamiento del departamento y de la empresa. También tendrá la posibilidad de liderar proyectos y participar de la estrategia empresarial (desde el punto de vista Regulatory). ¿Qué buscamos? Se valorará positivamente que el candidato reúna las habilidades, experiencia y cualidades que permitan desempeñar eficazmente las responsabilidades asociadas: • Estudios grado técnico (Química, Ciencia y Tecnología de los Alimentos, Biología etc.)., • Experiencia de 3 años en el ámbito de Calidad / Regulatory., • Conocimientos en Regulatory:, • Normativa CLP, • Normativa REACH, • Se valorará conocimientos en sistemas de calidad y medio ambiente, • Se valorará conocimientos en seguridad alimentaria: prerrequisitos, APPCC y certificaciones GFSI., • Se valorará conocimiento en certificación de producto ecológico, COSMOS, así como nociones en certificaciones KOSHER, HALAL y SAE., • Dominio del Inglés (hablado y escrito)., • Espíritu emprendedor y con ganas de participar en el crecimiento de una empresa dinámica., • Fuertes habilidades organizativas y de gestión del tiempo. ¿Qué ofrecemos? El puesto de trabajo representa una muy buena oportunidad para alguien que se quiera involucrar en un proyecto dinámico y con crecimiento. Las posibilidades de desarrollo tanto personal, como profesional son importantes, dado que el management estará encantado de involucrar a la persona en el plan estratégico. • Contrato estable, con periodo de prueba inicial., • Salario competitivo acorde a la experiencia aportada., • Oportunidad de crecimiento y formación interna. xqysrnh, • Ambiente de trabajo dinámico en una empresa en expansión.

Overview In this role you safeguard patient safety by coordinating pharmacovigilance across clinical development and post-marketing activities. You will collaborate with global teams to ensure regulatory compliance and robust safety monitoring. You provide operational and medical input for trials, safety reports, and submissions, while leading safety planning and medical reviews. Your work drives risk assessment and data-driven decisions to protect patients and support product safety strategy. Responsabilidades • Provide operational and medical support to clinical trials, including SAE management, medical review, reconciliation, unblinding, and safety monitoring, • Lead preparation and medical input for aggregate safety reports (DSURs) and periodic regulatory submissions, • Review safety-related sections of clinical documents (protocol synopses, Data Management Plans, Safety Topics of Interest), • Act as medical lead for the development of Safety Reporting Plans, • Participate in clinical study team meetings, including CRO collaboration, • Support non-interventional studies, market research, and registries (ICSR management and safety monitoring), • Conduct post-marketing safety surveillance, including medical review of data, • Support the Patient Safety Director and EU QPPV in regulatory duties, • Contribute to Pharmacovigilance Quality Management System and implementation of procedures, • Perform safety database tasks and signal detection as medical writer or reviewer, • Review PSURs and Risk Management Plans Requisitos principales, • Medical science degree, • Postgraduate training in pharmacovigilance, clinical safety, or epidemiology (preferred), • Experience in pharmacovigilance or clinical safety in a corporate setting (valued), • Proficiency in safety databases, • Strong understanding of GVPs and regulatory frameworks, • Cross-functional collaboration, • Attention to detail, • Effective communication with internal teams and CROs, • Safety databases proficiency, • ICSR management, • DSUR and PSUR review

Overview In this role you will serve as a global medical advisor and scientific expert across IQVIA divisions, guiding medical and scientific aspects of trials and business development. You will support investigators and project teams, review protocols and reports, and provide therapeutic area training. You’ll be involved in safety reviews, pharmacovigilance collaborations, and have 24/7 availability for urgent protocol questions, with regular travel. This is a high-impact position shaping clinical programs and patient outcomes within a leading CRO environment. Responsabilidades • Act as Global Medical Advisor on assigned projects and provide strategic medical guidance to project leaders, • Review protocols, IDBs, CRFs and CSR/patient narratives for medical accuracy and safety, • Provide therapeutic area training to project clinical teams and present at Investigator Meetings, • Review and clarify trial-related Adverse Events; participate in SAE case reviews with Pharmacovigilance, • Support AOSE analyses and collaborate with Pharmacovigilance on safety signal assessment, • Attend kickoff, weekly team, and client meetings; respond 24/7 to urgent protocol questions, • Travel 15-20% as needed, • Maintain up-to-date knowledge of scientific, clinical, regulatory, and competitive landscapes in applicable therapeutic areas Requisitos principales, • MD in Medicine with medical license appropriate to residence, • minimum 5 years of clinical medicine experience plus clinical trials experience (investigator or within Pharma/CRO/Biotech), • Board Certified, • experience or knowledge in Phase I or early clinical development, • Fluent English with extensive communication skills, • Knowledge of federal and local clinical research regulations and guidelines, • ability to work across diverse teams and provide medical leadership, • strong communication skills, • cross-functional collaboration, • problem-solving, • medical monitoring and safety review, • pharmacovigilance collaboration, • medical review of IDB/CRF/CSR

En Indra, buscamos incorporar un/a Responsable Técnico de Producto – Plataforma SAE para participar coordinando equipos multidisciplinares en un entorno internacional. Ser responsable técnico de producto y plataforma SAE, colaborando en el diseño técnico y evolución de soluciones. Conocimient

Barcelona, con habilidades resolutivas y motivación por formar parte de un proyecto en crecimiento y muy sólido.Dar soporte a la administración de cartera de alquileres temporales.Asistir y dar solución a los requerimientos de nuestros clientes.Soporte en la entrada y salida de los pisos.Sentido

En Celeste Luxury Living no vendemos casas.Somos una boutique inmobiliaria especializada en propiedades únicas, con muchísimo encanto y personalidad.Nos encanta el detalle, el trato exquisito y hacer que cada operación sea una experiencia memorable.Trabajamos en un ambiente cercano, cuidado y muy

We are looking for a Senior Legal Councel expert in Corporate to join our Impress Legal Team.The ideal candidate will have experience in consumer-facing companies within the healthcare or medical device sector, and a strong background in consumer law, regulatory compliance, litigation, and corporate

En ALTEN tenemos claro que el éxito de nuestros proyectos se debe a las personas que forman nuestro equipo.Por eso, si tienes experiencia como.Product Owner especializado en datos de clientes y análisis de negocio.Quieres construir hoy el mundo de mañana?.Cuáles serían tus principales funciones

Si tienes conocimientos técnicos en.En Fundación Somos F5 conectamos el talento digital oculto con empleos de calidad en el sector tecnológico.Formamos e impulsamos a personas diversas, especialmente de colectivos que enfrentan desafíos sociales, para reforzar equipos en las empresas y romper es

Eres un profesional de la climatización que sabe trabajar de forma autónoma, resolver averías y cuidar al cliente y las instalaciones como si fueran propias?.Somos una empresa especializada en instalaciones integrales y mantenimiento técnico de edificios de alta complejidad, trabajando en entorn

Solution Architect de Cloud Híbrido.Buscamos una persona capaz de diseñar soluciones cloud seguras y escalables, pero también de participar activamente en la relación con clientes, entender sus necesidades, defender propuestas y detectar nuevas oportunidades de negocio.Es una posición especialm

Empresa líder del sector eléctrico busca incorporar un/a Técnico/a de Producción Mecatrónico/a para integrarse en el área de Fabricación, participando directamente en los procesos de montaje, test y control de calidad del producto.Tareas y funciones a desempeñar:.Ejecutar los procesos produc

Coordinador/a de Operaciones y Fulfillment.Operaciones de FLiPO, dando soporte en la gestión del fulfillment, las compras y la coordinación entre áreas.Serás una pieza clave para que la operativa fluya sin fricciones entre atención al cliente y almacén, y tendrás participación activa en la m

Busco un perfil para asumir la.Una posició per a algú que conegui bé la.El repte passa per tenir una visió global de la cartera i de les operacions en curs: coordinar l’activitat de l’equip, prioritzar visites i seguiments, assegurar que cada nou actiu s’incorpora correctament i participar

Conceptualizar y redactar campañas para marcas de distintos sectores.Desarrollar ideas junto a dirección de arte y dirección creativa.Escribir para todo tipo de formatos: digital, social, audiovisual, gráfica y activaciones.Presentar ideas a cliente cuando el proyecto lo requiera.Cuidar el tono

Revisión y evaluación médica de acontecimientos adversos y SAEs procedentes de ensayos clínicos.

INMOECOLOGICAL SL es una empresa enfocada en la gestión y optimización de su patrimonio inmobiliario , residencial/comercial.Trabajamos con activos propios o de propiedad compartida en filiales mediante una gestión integral que combina visión estratégica, control financiero y conocimiento profu

Buscamos una persona organizada, proactiva y con buen nivel de inglés para incorporarse a nuestro equipo como.Administrativo/a Importación y Producción.Tendrás un papel clave en la gestión administrativa y documental de las operaciones de importación y producción, asegurando el control y traz

Especializados en alergia e inmunoterapia, salud animal y cuidado integral de la piel, nuestra prioridad es contribuir al aumento de la salud y el bienestar de la sociedad.La innovación y el desarrollo de productos de alto valor nos han llevado a ser una empresa global líder en segmentos especiali

En aProperties somos una inmobiliaria especializada en la comercialización de viviendas exclusivas en Barcelona, Madrid, Valencia y Mallorca.Nos caracterizamos por construir relaciones sólidas y duraderas basadas en la confianza y un servicio personalizado.Control de fianzas e ITP (Impuesto de tra

Buscando nuevos retos? ¿Quieres formar parte de nuestro equipo? 🚀.Con ilusión es como se cambian las cosas, y queremos contribuir a un futuro mejor gracias a la tecnología.Para conseguirlo no necesitamos héroes ni súper talentos, sino personas implicadas, motivadas, con muchas ganas de traba

ADMINISTRACIO DE FINQUES BALAGUER SL es una empresa dedicada a la administración y gestión de comunidades de propietarios, ubicada en Barcelona.Trabajamos ofreciendo un servicio cercano y profesional a comunidades, ayudando en su gestión diaria y en la resolución de incidencias.Buscamos mejorar

Diplomados/as o Graduados/as en Enfermería.Vigilancia de la Salud en Barcelona.Registro y gestión de resultados.Colaboración con el equipo médico y el Departamento de Vigilancia de la Salud.Desplazamientos a centros de trabajo mediante.Grado o Diplomatura en Enfermería.Vigilancia de la Salud, E

Flujos de Datos y Pipelines de Procesamiento.Buscamos un perfil con trayectoria consolidada en arquitectura de datos, capaz de diseñar y evolucionar soluciones escalables, seguras y trazables en entornos cloud, híbridos y distribuidos.Cuáles serán tus responsabilidades?.Diseñar y evolucionar ar

Recepcionista y auxiliar administrativo en Clínica veterinaria especializada en animales exóticos.Els Altres es una clínica veterinaria especializada en animales exóticos y mascotas no convencionales.Trabajamos con la convicción de que todas las especies merecen una atención cariñosa, respetu

Vidra Foc continúa creciendo y queremos incorporar a nuestro equipo comercial un/a Backoffice de Ventas.Se trata de una posición temporal, con posibilidades reales de incorporación indefinida, cuyo objetivo principal será dar soporte administrativo y operativo al equipo comercial, contribuyendo

Definición y validación de procesos de inyección.Supervisión del equipamiento de serie de prototipos, garantizando la correcta aplicación de los estándares y acabados.Elaboración y actualización de.Coordinación con los departamentos internos de calidad, metrología y logística para asegura

En Deloitte estamos comprometidos con generar un impacto en la sociedad, en nuestros clientes y en ti.Te unirás al equipo de Business Process Solutions (BPS) de Deloitte, donde acompañamos a grandes, medianas y pequeñas empresas (nacionales e internacionales) en todo lo relacionado con la gestió

En Grupo INVOIN, buscamos un/a.Ingeniero/a Senior de Procurement.Buscamos un perfil senior con experiencia en la.Zona Franca del Puerto de Barcelona.Participación en un importante proyecto industrial desarrollado bajo modalidad EPCM.Identificar y seleccionar potenciales.Elaborar listas cortas de pr

Por eso, si cuentas con experiencia en sistemas de calidad farmacéuticos y buscas participar en un proyecto dentro de un entorno GMP, queremos impulsar tu talento y acompañarte en tu desarrollo profesional.Tienes experiencia gestionando controles de cambio, desviaciones y CAPAs? ¿Te desenvuelves

Office Assistant | Administrativo/a.Se trata de una posición estable a.Asegurar el correcto funcionamiento diario de la oficina, proporcionando.Gestionarás la organización y el correcto funcionamiento de la oficina: suministros, espacios, salas de reuniones y otras necesidades del día a día.Coo

Martech Engineer Associate Manager.Para este rol necesitamos un perfil capaz de coordinar iniciativas y personas dentro de proyectos, combinando visión operativa, capacidad de organización y orientación al cliente.Esperamos que impulses la colaboración entre equipos, contribuyas a la toma de dec

Con SAFTI puedes abrir tu propio negocio inmobiliario digital!.Desarrolla tu negocio escalable en el sector inmobiliario a nivel internacional y crea un equipo para generar una estructura sólida que te permita disparar tus ingresos de forma ilimitada, con todo el soporte y la infraestructura de una

Galtea is building the evaluation platform for AI teams.We help companies ship better AI, faster, by making it easy to test, evaluate, and monitor AI agents and LLM-powered products at scale.We're backed by top-tier investors and working with some of the most sophisticated AI teams in Europe, includ

Analista de Microbiología Ambiental (Turno de Tarde).Compañía farmacéutica internacional en crecimiento, especializada en la fabricación de medicamentos estériles y productos inyectables.La organización opera bajo estrictos estándares GMP, con instalaciones avanzadas y un fuerte enfoque en l

Gestor/a de Garantías | Sector Automoción 🏍️.Importante y reconocida empresa fabricante de motocicletas y vehículos, ubicada en el área metropolitana de Barcelona, busca incorporar un/a Gestor/a de Garantías para contribuir a la fidelización de clientes y al crecimiento de los ingresos.Ge