Clinical Affairs Program Manager Spain

hace 1 semana

spain Chronos Consulting A tiempo completo

Job Description Our client is a global medical device company, a pioneer of the MR-guided focused ultrasound technology which is a game-changing innovation. They are looking for a Clinical Affairs Program Manager Europe. The role is % remote with up to 40% travel and based in Europe. As part of the global clinical affairs team, you will be responsible for developing strategies for a successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include management of clinical trials approvals with local IRBs and/or Competent Authorities. Required Skills and Experience: 1) BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines 2) Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantage 3) Additional 4+ years direct experience in clinical trial management 4) Solid track record in successfully executing Phase I – III clinical trials 5) Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. Additional FDA and or Health Canada experience would provide a strong advantage but will not be required. 6) Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting 7) Knowledge of electronic data capture systems and web-based clinical trial management tools 8) Excellent interpersonal, written / verbal communication, computer & organizational skills, strong program management and financial skills 9) Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage 10) Collaborative team player with strong abilities to operate independently 11) Willing & able to travel domestically and internationally, as required (up to 40%) Responsibilities: Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc. Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budget Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trials Direct/Manage necessary clinical trial approvals from IRBs/ECs, and ensure studies are on track for site initiation, patient recruitment and enrollment; take corrective actions where necessary to address issues Develops budget for all clinical projects and adhere to company financial goals Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programs Participate in the development of SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures Identify clinical training needs and develop training materials for in-house and clinical site use

  • Clinical Scientist/Senior Clinical Scientist

    hace 2 días

    Remote (Spain) Catalyst Clinical Research A tiempo completo

    As a Clinical Scientist you are a key member in the Clinical Oncology Operations, Clinical Science Team. Your main responsibility is to review, understand, and assess clinical data before it is reviewed by Medical/Client. You will also communicates and present the relevant trends and findings of the clinical review to the Study Team and the Client. You will...

  • Quality Regulatory Manager

    hace 2 semanas

    Spain Elemed A tiempo completo

    Title : RAQA Lead - Spain and Portugal Location : Barcelona, Spain Contact : ¿Está considerando presentar su candidatura para este trabajo? Compruebe todos los detalles en esta descripción del puesto y luego haga clic en "Solicitar". The company Are you someone who has Iberia-wide regulatory experiences and are looking for the next step in your medical...

  • Head Of Clinical Evaluation

    hace 2 semanas

    Spain iVascular A tiempo completo

    At iVascular, we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of cardio, neuro, and endovascular diseases and to become a reference in the vascular field by enhancing the value of technology and innovation.Si sus habilidades, experiencia y cualificaciones coinciden con las de esta...

  • Quality Regulatory Manager

    hace 2 semanas

    Spain Elemed A tiempo completo

    Title: RAQA Lead - Spain and Portugal Location: Barcelona, Spain Contact: Aunque la experiencia profesional y las cualificaciones son clave para este puesto, asegúrese de comprobar si posee las habilidades interpersonales preferibles antes de solicitar, si se requieren. The companyAre you someone who has Iberia-wide regulatory experiences and are looking...

  • Clinical Evaluation Internship

    hace 2 semanas

    Spain iVascular A tiempo completo

    At iVascular , we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of cardio , neuro , and endovascular diseases and to become a reference in the vascular field by enhancing the value of technology and innovation. Inscríbase ahora, lea los detalles del trabajo desplazándose hacia abajo....

  • Head Of Clinical Evaluation

    hace 2 semanas

    Spain iVascular A tiempo completo

    At iVascular , we are dedicated to the design, manufacturing, production, and commercialization of medical devices for the treatment of cardio , neuro , and endovascular diseases and to become a reference in the vascular field by enhancing the value of technology and innovation. ¡Inscríbase sin demora! Se espera un gran volumen de solicitantes para el...

  • Program Manager

    hace 1 semana

    Barcelona, Connecticut, Spain TransPerfect A tiempo completo

    Job description The Program Manager will be responsible for the operational success of TransPerfect ensuring seamless team collaboration and development, program delivery, strategic customer service and quality control and evaluation.A successful Program Manager will have solid program management skills, excellent problem solving skills, and the ability to...

  • Program Manager

    hace 13 horas

    Madrid, Maryland, Spain TransPerfect A tiempo completo

    Job description Position summary:The Program Manager is a key player in contributing to the company´s operational success. They are responsible for ensuring seamless team collaboration and development, program delivery, strategic customer service and quality control and evaluation.A successful Program Manager will have solid program management skills,...

  • Regulatory Affairs Manager CMC

    hace 7 días

    Spain Oxford Global Resources A tiempo completo

    Oxford Global Resources is seeking a Global CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma company to support headquartered in Barcelona through our consulting services division. Key Responsibilities: Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC...

  • Regulatory Affairs Project ManagerNonStop Consulting

    hace 1 semana

    spain NonStop Consulting A tiempo completo

    Regulatory Affairs Project Manager Location: Remote/Home Working EU Wide Introduction Our client is seeking a highly skilled and motivated Regulatory Affairs Project Manager to join their dynamic team. This role offers the opportunity to work at the forefront of regulatory science, contributing to the successful registration and market approval of active...