Study Start Up Lead

3 semanas atrás


São Paulo, Brasil F. Hoffmann-La Roche Ag Tempo inteiro

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued and respected for who you are, allowing you to thrive both personally and professionally. Join Roche, where every voice matters. Study Start up Lead (SSUL) – location: Sao Paulo, full time. Posted today. End date Dec 8. The Position As a member of the PDG Country Study Start‑Up Team, your primary focus is to drive and facilitate efficient study start‑up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start‑up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators and clinical site staff. Collaboration with local internal and external country teams, global study teams and CROs is essential to this position. In this role you will focus on the efficient and compliant initiation of Roche‑sponsored clinical trials by developing and implementing effective start‑up strategies, overseeing start‑up operations and driving process improvements at the country and site level while maintaining regulatory compliance. The Opportunity Leading the country strategy for study start‑up, driving efficiency, innovation and collaboration with external stakeholders. Contribute as a member of the Country Leadership Team (LT) where applicable. Overseeing start‑up operations and ensuring timely and efficient site activation and regulatory compliance. Ensuring alignment with global strategies and timelines. Managing amendments throughout the study lifecycle. Identifying and driving opportunities for process automation, standardisation and innovation. Collaborating with regional and global counterparts to harmonise systems and improve timelines. Participating in external industry collaborations to influence country start‑up environments. Engaging with government and institutional bodies to align on clinical trial policies and practices (e.g. with Ethics Boards, Health Authorities). Who you Are Degree (MD, PhD, MA/ MS, BA/ BS) in life sciences or equivalent. Postgraduate degree or master’s degree highly desirable. Demonstrated experience in clinical trial start‑up, regulatory submissions and cross‑functional collaboration. Strong understanding of ICH‑GCP, EU CTR and local regulatory environments. Experience managing vendor / CRO relationships. Proven leadership or line‑management experience (for People Leads). Fluency in written and spoken English is mandatory. Fluency in written and spoken language of the host country is mandatory. Relocation benefits are not available for this position. Roche is an Equal Opportunity Employer. #J-18808-Ljbffr


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