Clinical Study Coordinator
hace 4 días
In a nutshell Puede obtener más detalles sobre la naturaleza de esta vacante y lo que se espera de los solicitantes leyendo la información a continuación. Position: Clinical Study Coordinator Location: Madrid, Hibrid Experience: 4+ years in international clinical trial coordination Want to know more? mAbxience is a global biopharmaceutical company committed to innovation and excellence in the development and manufacturing of biotechnological medicines. We operate with a strong focus on quality, regulatory compliance, and scientific rigor to improve patient outcomes worldwide. What are we looking for? Oversee and ensure the proper execution and follow-up of clinical trials, managing CROs and vendors to meet timelines, quality standards, and regulatory requirements. Design and manage clinical trial plans, identifying risks and implementing corrective actions. Coordinate site and investigator selection, budget management, and vendor contracts. Ensure compliance with GCP, FDA, EMA, ICH guidelines, and internal procedures. Manage regulatory documentation and submissions, maintaining audit readiness. Supervise clinical trial monitoring, investigational product handling, and patient recruitment strategies. Collaborate with pharmacovigilance teams to ensure timely reporting and management of safety events. Support quality management through monitoring reports, deviation handling, and protocol amendments. Maintain effective communication with internal teams, CROs, investigators, and regulatory authorities. xcskxlj What do you need?
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Monterroso, España Kapadi A tiempo completoKapadi is a full service CRO that focuses on complex oncology indications including immunotherapy and cellular therapies. We know that innovative research requires innovative operations and we've built that into our culture, systems and processes. We have an infrastructure to enhance access to patients and integrated technology to provide higher quality and...
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Clinical Project Manager
hace 4 días
Monterroso, España OPIS A tiempo completoThe Senior Clinical Project Manager reports to the Clinical Operations Manager and is responsible to manage the local and international projects in compliance with contractual requirements, timelines, standard operating procedures and relevant regulations and legislations. He/she leads the internal study team allocated on his/her projects ensuring that all...
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Regulatory Submission Specialist
hace 4 días
Monterroso, España OPIS A tiempo completoDue to our ongoing global expansion, we have a great opportunity for a Regulatory Submissions Specialist to join our growing regulatory team in Taiwan, on a fully remote basis. Desplácese hacia abajo para ver todos los requisitos del puesto y las responsabilidades que pueden esperar los candidatos seleccionados. We are looking for someone who can...