Study Start Up Lead

Job description

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 PositionAt Roche 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 Clinical Operations Study Start-Up team, you will drive and facilitate the efficient initiation of clinical trials, ultimately helping to deliver innovative treatments to patients. You'll 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 as a functional lead to make a meaningful impact by ensuring seamless trial execution for patients, investigators, and clinical site staff. The Role This role focuses on driving the efficient and compliant initiation of Roche-sponsored clinical trials by implementing effective start-up strategies and coordinating operations while maintaining strict regulatory compliance. Working as a dedicated functional process lead, you will hold operational ownership for start-up execution across your designated studies. Lead Country Strategy: You will drive and implement the country strategy for study start-up, enhancing efficiency, innovation, and proactive collaboration with external stakeholders. Oversee Operations: You will take end-to-end operational ownership of start-up activities to ensure timely site activation, operational readiness, and regulatory compliance for your studies. Manage Clinical Trial Submissions: You will lead the development, preparation, compilation, and execution of submission packages for regulatory bodies and Ethics Committees / Health Authorities. You will directly manage protocol amendments, respond to Requests for Information (RFIs), ensure timely document archiving in the Trial Master File (TMF), track submissions in internal systems, and maintain deep awareness of local regulatory requirements. Strategize on Budget & Contracts: You will provide strategic planning and hands-on execution for budgeting and contract management—developing FMV-based site budget strategies and negotiating directly with key internal and external stakeholders. Drive Process Improvements: You will proactively identify, advocate for, and implement 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, align operational workflows, and improve start-up timelines. Who You Are You have a degree (MD, PhD, MA/MS, BA/BS) in life sciences or a related field. A postgraduate degree is highly desirable. You have at least 4 years of demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration. 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 the language(s) of the host country. Who we areA 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.