Clinical Affairs Program Manager Spain
hace 2 semanas
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
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Clinical Scientist/Senior Clinical Scientist
hace 6 días
Remote (Spain) Catalyst Clinical Research A tiempo completoAs 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...
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Clinical Project Manager
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Spain LHH A tiempo completoClinical Project Manager – Neuroscience ResearchSe anima a todos los posibles solicitantes a que se desplacen y lean la descripción completa del puesto antes de presentar su candidatura.Are you passionate about advancing clinical research in neurodegenerative disorders? We are looking for a Clinical Project Manager to lead the planning, coordination, and...
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Head Of Clinical Evaluation
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Spain iVascular A tiempo completoAt 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...
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Senior Clinical Research Associate
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Spain Upsilon Global A tiempo completoUpsilon Global are seeking a freelance SCRA based in the Galicia region of NW Spain to support an ongoing study into a respiratory virus. This is an ongoing study linked to 1-2 key sites in the region, with local Galician language being essential for the ICFs. Desplácese hacia abajo para encontrar los detalles completos de la oferta de trabajo, incluyendo...
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Program Manager
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Program Manager
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Madrid, Maryland, Spain TransPerfect A tiempo completoJob 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,...
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Regulatory Affairs Project ManagerNonStop Consulting
hace 2 semanas
spain NonStop Consulting A tiempo completoRegulatory 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...
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Clinical Sales Specialists Anesthesiology
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spain Chronos Consulting A tiempo completoJob Description Clinical Sales Specialists Anesthesiology Location: home-office based, Spain Our client develops monitoring devices and applications to objectively assess patient’s physiological pain response level, spearheading pain management helping anesthesiologists. The Clinical Sales Specialist is accountable for direct and indirect sales of medical...
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spain NonStop Consulting A tiempo completoRegulatory Affairs Project Manager 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 substances under EU Regulation 1107/2009...
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Regulatory Affairs Manager
hace 4 días
Av. de Font i Sagué, , Terrassa, Barcelona, Spain Syntegon Telstar A tiempo completoCompany Description Syntegon Telstar S.R.U. is a company of the Syntegon group, which operates worldwide.As a brand specialized in the development of GMP projects of consulting, engineering, construction and integrated process equipment, we serve companies linked to the life sciences market (pharmaceutical and biotechnology, healthcare, cosmetics, veterinary...
