Study Start-Up Lead

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, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Study Start-Up Lead at Roche, you will be responsible for the efficient and compliant initiation of Roche-sponsored clinical trials. In this role, you will create and implement start-up strategies, oversee trial initiation, and ensure regulatory compliance while fostering innovation and operational excellence. You will collaborate with internal and external stakeholders across local, regional, and global levels, ensuring alignment with Roche’s global priorities and delivering value for patients, investigators, and partners. The Opportunity Develop and implement effective study start-up strategies that ensure timely and compliant trial initiation. Oversee start-up operations, including site activation and regulatory coordination, ensuring adherence to global standards. Lead the preparation, submission, and archiving of Informed Consent Forms (ICFs). Manage clinical trial submissions, amendments, and site documentation throughout the study lifecycle. Drive process improvements, including automation, standardization, and innovation at country and site levels. Oversee budget planning, contract management, and payment processes, ensuring legal and financial compliance. Collaborate with CROs, authorities, and industry stakeholders to improve timelines and influence the clinical trial environment. Who You Are Degree in life sciences (MD, PhD, MSc, or equivalent); postgraduate degree preferred. Proven experience in clinical trial start-up, regulatory submissions, and vendor/CRO management. Strong knowledge of ICH-GCP, EU CTR, and local regulatory frameworks. Excellent leadership, communication, and problem-solving skills, with the ability to guide teams in complex, global environments. Fluency in English and Spanish, both written and spoken. Relocation benefits are not available for this position. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.