Trabajos sae en El Prat De LlobregatCrear alertas

En BrainRPO buscamos un/a Cybersecurity Compliance Senior Specialist (ISO 27001 & ENS) para uno de nuestros clientes del sector industrial, actualmente inmerso en un importante proceso de transformación tecnológica. Buscamos una persona con experiencia demostrable implantando y evolucionando ISO 27001 y el Esquema Nacional de Seguridad (ENS), que quiera asumir un rol estratégico con un elevado nivel de autonomía e impacto, impulsando la definición, implantación y evolución del Sistema de Gestión de Seguridad de la Información (ISMS) de una compañía en pleno crecimiento. ¿Cuál será tu misión? Serás responsable de definir, mantener y mejorar continuamente el marco de Gobierno de la Ciberseguridad de la organización, garantizando el cumplimiento de los principales estándares y regulaciones, así como impulsando una cultura de seguridad alineada con la estrategia de negocio. Trabajarás de forma muy cercana con la Dirección Técnica y participarás activamente en la evolución de la estrategia de ciberseguridad de la compañía. Principales responsabilidades: • Liderar la implantación, mantenimiento y mejora continua del Sistema de Gestión de Seguridad de la Información (ISMS)., • Definir, revisar y mantener políticas, procedimientos, estándares y controles de seguridad., • Liderar la implantación y evolución de ISO 27001 y del Esquema Nacional de Seguridad (ENS)., • Coordinar auditorías internas y externas, certificaciones y actividades de cumplimiento normativo., • Realizar análisis y evaluación de riesgos de ciberseguridad, definiendo y realizando el seguimiento de los planes de mitigación., • Elaborar indicadores, cuadros de mando e informes para la Dirección y los comités de seguimiento., • Colaborar con las distintas áreas de la organización para integrar los requisitos de ciberseguridad en proyectos y procesos., • Impulsar iniciativas de concienciación y cultura de ciberseguridad dentro de la compañía., • Dar soporte al área de Gobierno de Ciberseguridad en la mejora continua del marco de seguridad corporativo. Buscamos un perfil con: • Titulación universitaria en Ingeniería Informática, Telecomunicaciones, Ingeniería Industrial o similar., • Más de 7 años de experiencia en Gobierno, Riesgos y Cumplimiento (GRC) o Gestión de la Seguridad de la Información., • Experiencia demostrable liderando la implantación y mantenimiento de ISO 27001 y del Esquema Nacional de Seguridad (ENS)., • Experiencia desarrollando Sistemas de Gestión de Seguridad de la Información (ISMS)., • Experiencia en gestión de riesgos, auditorías y cumplimiento normativo., • Capacidad para definir políticas, procedimientos y controles de seguridad., • Nivel alto de inglés. Se valorará además: • Certificaciones como ISO 27001 Lead Implementer, ISO 27001 Lead Auditor, CISM o CISA., • Experiencia en entornos industriales o del sector automoción., • Conocimientos de UNECE R155, ISO/SAE 21434, TISAX o IEC 62443., • Experiencia trabajando con equipos multidisciplinares y proveedores. ¿Qué ofrecemos? • Incorporarte a un proyecto empresarial sólido y en plena expansión., • Asumir una posición estratégica con gran visibilidad dentro de la organización., • Entorno altamente tecnológico y orientado a la innovación., • Contrato indefinido., • Salario fijo + otros beneficios sociales. Si buscas un proyecto donde puedas dejar huella liderando el cumplimiento y la gobernanza de la ciberseguridad de una organización en crecimiento, estaremos encantados de conocerte.

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

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.

We’re building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.Our purpose is simple: to transform patients’ lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward. If you care differently, you belong here. Help shape the future of patient safety.At Almirall, we are committed to improving the lives of patients through science, innovation, and care. We are looking for a medical safety professional who is passionate about protecting patients and ensuring the highest standards of pharmacovigilance across our investigational and marketed products.In this role, you will work at the intersection of clinical development, post-marketing surveillance, and regulatory compliance, collaborating with global cross-functional teams to ensure that patient safety remains at the heart of everything we do.POSITION SUMMARY / MISSIONResponsible for the management of corporate pharmacovigilance activities in collaboration with internal and external stakeholders, ensuring the safety of Almirall’s marketed and investigational products. This role provides operational and medical support across clinical development and post-marketing safety surveillance, contributing to regulatory compliance and patient protection.CORE RESPONSIBILITIESProvide operational and medical support to clinical trial activities, including SAE management, medical review, reconciliation, unblinding, and safety monitoringLead the preparation and medical input for aggregate safety reports (e.g., DSURs) and other periodic regulatory submissionsReview safety-related sections of clinical documentation, including protocol synopses, Data Management Plans, and Safety Topics of InterestAct as medical lead for the development of Safety Reporting Plans Participate actively in clinical study team meetings, both internally and with CROs Support non-interventional studies, market research, and registries, including ICSR management and safety monitoringConduct post-marketing safety surveillance, including medical review and assessment of safety data Support the Patient Safety Director and EU QPPV in fulfilling internal and regulatory responsibilities Contribute to the Pharmacovigilance Quality Management System and ensure implementation of relevant proceduresPerform tasks related to safety databases and signal detection (as medical writer or reviewer) Conduct review of PSURs and Risk Management PlansREQUIRED EDUCATION AND EXPERIENCE Medical science degree and Postgraduate training in pharmacovigilance, clinical safety, or epidemiology are preferred.Experience in pharmacovigilance or clinical safety within a corporate setting is highly valuedPREFERRED SKILLS AND COMPETENCIESProficiency in safety databasesStrong understanding of Good Pharmacovigilance Practices (GVPs) and applicable regulatory frameworksSummaryLocation: SANT FELIU DE LLOBREGATType: Full time

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.

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. 3. 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.

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 tobe 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

The medical department consists of a Chief Medical Officer, Medical Directors, Sr Medical Directors, Medical Writers, and Safety Associates. The Medical Director provides medical and scientific support to clinical research programs, study teams and investigators. The Medical Director also provides review, advice, and leadership for potentially or awarded clinical research programs. The Medical Director role is a team member participant role and functions in a matrix report to project teams much like other members of the project teams. The primary role of Medical Director is to provide medical oversight for clinical trials by serving as Medical Monitor for studies conducted by IQVIA Biotech Clinical on behalf of sponsor companies. The principal function of a Medical Monitor is to serve as primary contact for the sponsor medical team and to serve as front line medical resource to support the project team. The Medical Monitor is customarily available 24/7 to answer questions from site coordinators and investigators on protocol inclusion/exclusion criteria, protocol clarifications, and compliance issues, and to provide review of alert labs per sponsor preference. Major duties of the Medical Director are outlined below: • Provides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation, and reporting., • Ensures medical activities run according to GCP and operate with highest efficiency., • Establishes and maintains a network of medical/scientific consultants, etc., • Supervises and manages Medical Director activities., • Interacts with clients regarding drug development programs, study design and protocol., • Reviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints., • Interacts in team approach to develop statistical and data management sections of the protocol., • Reviews the final protocol for clinical, safety and efficacy variables., • Provides project team training on protocol and/or therapeutic areas., • Assists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection., • Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators, and site staff and/or participation in teleconference and WebEx presentations., • Presents protocol and/or safety reporting information at investigator meetings., • Develops project medical monitoring plans as requested., • Provides on call coverage for protocol queries and site support., • Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and patient eligibility issues., • Verifies the medical accuracy of patient safety data and maintains an ongoing assessment of the safety profile of the study., • Provides medical review of SAE reporting, writes and/or reviews SAE narratives, and works with the Safety Management Department to track SAEs and follow-up on outstanding safety queries, interacts with sponsor and discusses safety issues with site as needed., • Reviews IND/SUSAR Safety Reports (per sponsor preference), updates to Investigator Brochures, and annual IND reports with sponsor data., • In consultation with the sponsor, follow procedures for acquiring knowledge of subject treatment assignments (i.e. breaking the blind)., • Interact with appropriate FDA officials concerning safety and other study related issues, as requested., • Provides medical review of eCRFs for clinical accuracy., • Provides medical review of data analysis plan., • Reviews safety fields at case freeze for reconciliation (if needed)., • Works with data group to reconcile SAE events as needed., • Reviews medical coding of adverse events, laboratory data and concomitant medications for accuracy, coherence, consistency, and trends., • Reviews data tables, listings, and figures., • Reviews and/or writes portions of final clinical study report., • May assist sponsor in choosing committee members., • May serve as a non-voting member to convene and organize proceedings., • May develop operating guidelines in conjunction with committee members and submits these to sponsor for review., • May determine data flow with sponsor to ensure reporting accuracy., • Can ensure DSMB feedback is given to sites for IRBs., • All DSMB activities are usually managed by the IQVIA Biotech Oversight Management Group and not the IQVIA Biotech medical monitor., • Work with Business Development to actively solicit new business for Novella Clinical, including assistance with marketing presentations and proposal development., • Supports business development activities with proposal development and sales presentations., • Participates in feasibility discussions relating to specific project proposals., • Obtain literature searches to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc., • Assists with drafting of standard operating procedures and working practices regarding all Medical Director activities., • Participate in a variety of team quality improvement efforts as necessary., • Perform other related duties as assigned or requested by the Chief Medical Officer., • Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education., • 10 years of experience is required which can include medical practice (hospital/clinic), academia, clinical research, or drug development., • 3-5 years of biopharmaceutical (industry) experience is preferred which can be part of the 10-year experience., • Ability to work in partnership with a multidisciplinary group of colleagues, including translating concepts into practical approaches and promoting consensus., • Outstanding ability to work independently with minimal supervision, ability to work effectively within a team, and matrix environment., • Ability to organize and work efficiently on several projects, each with specific requirements and/or shifting priorities., • Excellent oral and written communications skills as well as interpersonal skills are essential., • Board Certified / Board Eligible: Oncology (Required), • Preferably : Urologist / Surgical Oncology IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. #J-18808-Ljbffr

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 tobe 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

En Brain RPO buscamos un/a Cybersecurity Compliance Senior Specialist (ISO 27001 & ENS) para uno de nuestros clientes del sector industrial, actualmente inmerso en un importante proceso de transformación tecnológica. Buscamos una persona con experiencia demostrable implantando y evolucionando ISO 27001 y el Esquema Nacional de Seguridad (ENS), que quiera asumir un rol estratégico con un elevado nivel de autonomía e impacto, impulsando la definición, implantación y evolución del Sistema de Gestión de Seguridad de la Información (ISMS) de una compañía en pleno crecimiento. ¿Cuál será tu misión? Serás responsable de definir, mantener y mejorar continuamente el marco de Gobierno de la Ciberseguridad de la organización, garantizando el cumplimiento de los principales estándares y regulaciones, así como impulsando una cultura de seguridad alineada con la estrategia de negocio. Trabajarás de forma muy cercana con la Dirección Técnica y participarás activamente en la evolución de la estrategia de ciberseguridad de la compañía. Principales responsabilidades: Liderar la implantación, mantenimiento y mejora continua del Sistema de Gestión de Seguridad de la Información (ISMS). Definir, revisar y mantener políticas, procedimientos, estándares y controles de seguridad. Liderar la implantación y evolución de ISO 27001 y del Esquema Nacional de Seguridad (ENS). Coordinar auditorías internas y externas, certificaciones y actividades de cumplimiento normativo. Realizar análisis y evaluación de riesgos de ciberseguridad, definiendo y realizando el seguimiento de los planes de mitigación. Elaborar indicadores, cuadros de mando e informes para la Dirección y los comités de seguimiento. Colaborar con las distintas áreas de la organización para integrar los requisitos de ciberseguridad en proyectos y procesos. Impulsar iniciativas de concienciación y cultura de ciberseguridad dentro de la compañía. Dar soporte al área de Gobierno de Ciberseguridad en la mejora continua del marco de seguridad corporativo. Buscamos un perfil con: Titulación universitaria en Ingeniería Informática, Telecomunicaciones, Ingeniería Industrial o similar. Más de 7 años de experiencia en Gobierno, Riesgos y Cumplimiento (GRC) o Gestión de la Seguridad de la Información. Experiencia demostrable liderando la implantación y mantenimiento de ISO 27001 y del Esquema Nacional de Seguridad (ENS). Experiencia desarrollando Sistemas de Gestión de Seguridad de la Información (ISMS). Experiencia en gestión de riesgos, auditorías y cumplimiento normativo. Capacidad para definir políticas, procedimientos y controles de seguridad. Nivel alto de inglés. Se valorará además: Certificaciones como ISO 27001 Lead Implementer, ISO 27001 Lead Auditor, CISM o CISA. Experiencia en entornos industriales o del sector automoción. Conocimientos de UNECE R155, ISO/SAE 21434, TISAX o IEC 62443. Experiencia trabajando con equipos multidisciplinares y proveedores. ¿Qué ofrecemos? Incorporarte a un proyecto empresarial sólido y en plena expansión. Asumir una posición estratégica con gran visibilidad dentro de la organización. Entorno altamente tecnológico y orientado a la innovación. Contrato indefinido. Salario fijo + otros beneficios sociales. Si buscas un proyecto donde puedas dejar huella liderando el cumplimiento y la gobernanza de la ciberseguridad de una organización en crecimiento, estaremos encantados de conocerte.

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.

Certificaciones como ISO 27001 Lead Implementer, ISO 27001 Lead Auditor, CISM o CISA. Experiencia demostrable liderando la implantación y mantenimiento de ISO 27001 y del Esquema Nacional de Seguridad (ENS). Conocimientos de UNECE R155, ISO/SAE 21434, TISAX o IEC 62443.

Se busca una persona para el puesto de control de calidad en seguridad alimentaria en una empresa del sector alimentario ubicada en Zona Franca (Barcelona). Las funciones principales incluyen garantizar el cumplimiento del sistema de gestión de calidad y seguridad alimentaria, impulsar la cultura de seguridad alimentaria entre el personal, y ser miembro del equipo APPCC. También se colabora con el responsable de normas IFS y SAE, se gestionan proveedores, se cumplimentan registros de calidad y se controla la documentación del protocolo USA. Otras tareas son la homologación de proveedores, participación en ejercicios de trazabilidad y simulacros de crisis alimentarias, colaboración en auditorías y formaciones, y seguimiento de no conformidades y reclamaciones de clientes. El horario es de jornada completa, 40 horas semanales de lunes a viernes en turno de mañana, de 09:00 a 18:00 con los descansos establecidos por ley.