Study Start Up Lead

En Roche puedes ser tú mismo y sentirte valorado por tus cualidades únicas. Nuestra cultura fomenta la expresión personal, el diálogo abierto y las conexiones genuinas, donde eres valorado, aceptado y respetado por lo que eres, permitiéndote prosperar tanto de manera personal como profesionalmente. Así es como buscamos prevenir, detener y curar enfermedades y asegurarnos de que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Únete a Roche, donde cada voz importa. La posición At Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. As a key member of our Country Study Start-Up team, you will drive and facilitate the efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You will work in a highly collaborative and cross-functional environment, where you have the opportunity to influence and shape our clinical trial delivery strategy. This is a unique opportunity to use your expertise to make a meaningful impact by ensuring seamless trial execution for patients, investigators, and clinical site staff. The Role ● Lead Country Strategy: You will lead the country strategy for study start-up, driving efficiency, innovation, and collaboration with external stakeholders. ● Oversee Operations: You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance. ● Drive Process Improvements: You will identify and lead opportunities for process automation, standardization, and innovation at both the country and site levels. ● Collaborate and Harmonize: You will collaborate with regional and global counterparts to harmonize systems and improve timelines. ● Manage Clinical Trial Submissions: You will oversee the development and management of clinical trial submissions and amendments, ensuring regulatory coordination. ● Strategize on Budget ; Contracts: You will provide strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating with internal and external stakeholders. ● Influence the Environment: You will participate in external industry collaborations to influence the countrys start-up environment. Who You Are ● You have a degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field. A postgraduate degree in clinical trials or clinical research is highly desirable. ● You have demonstrated experience in clinical trial start-up in Spain, regulatory submissions, and cross-functional collaboration. ● Proven track record in managing site relationships with a customer centric mindset and managing complex clinical trials start-up (e.g. at least 2-year previous experience as a Clinical Trial Monitor). ● You possess a strong understanding of ICH-GCP, EU CTR, and local regulatory environments. ● You have excellent communication, interpersonal, and problem-solving skills, with a collaborative mindset. ● You are fluent in both written and spoken English, and in Spanish. ● Ability to manage multiple priorities and work in a fast-paced, dynamic environment. ● Ability to travel if needed. Quienes somos Alcanzar un futuro más saludable es lo que nos impulsa a innovar. Juntos, más de 100.000 empleados en todo el mundo están dedicados a avanzar en la ciencia, asegurando que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Nuestros esfuerzos resultan en más de 26 millones de personas tratadas con nuestros medicamentos y más de 30 mil millones de pruebas realizadas con nuestros productos de Diagnósticos. Nos damos apoyo mutuamente para explorar nuevas posibilidades, fomentar la creatividad y mantener altas nuestras ambiciones, para poder ofrecer soluciones sanitarias que cambian la vida e impactan a nivel global. Construyamos juntos un futuro más saludable. Roche es una empresa que ofrece igualdad de oportunidades.