New

Global Study Lead

Roche Holdings Inc.
United States, Indiana, Zionsville
123 North Main Street (Show on map)
Aug 13, 2025
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 Are you passionate about leading global clinical studies that push the boundaries of diagnostics and healthcare innovation? This role offers an exciting chance to take full accountability for global study deliverables, ensuring excellence in quality, budget management, and timelines. You will work at the forefront of diagnostics research, developing innovative study designs in collaboration with internal and external experts. You will be responsible for studymanagementactivities for the assigned studies within the PHCS US I or US II Sub Chapter underthe Study DeliveryPHCS Chapter. Join our team and drive evidence generation that supports global strategies while advancing healthcare outcomes for patients worldwide. The Opportunity: Lead study teams: delivery of high-quality studies within budget and timelines Collaborate on design: work with cross-functional teams, including Regulatory Affairs, R&D, and external partners, to develop and implement study designs and evidence generation plans Oversee study phases: including planning, start-up, conduct, and close-out Manage budgets: accountable for study-level budget management and performance tracking Compliance: ensure adherence to global regulations, guidelines, and audit/inspection readiness Build stakeholder relationships: drive operational excellence by maintaining relationships with key stakeholders and service providers including CRO Who You Are: (Required) In the PHCS area you are a clinical trial expert with experience in managing sophisticated, multi-phase studies. You bring a proven track record of managing sophisticated studies and delivering results: Clinical trial management: At least 5- 8 years of experience preferably within diagnostics, and in the Infectious Disease area Education: Bachelor's degree in Life Sciences or relevant field, with knowledge of product development and clinical operations Leadership: skilled in leading study teams and building collaborative relationships with key stakeholders, including CROs and external partners Problem-Solving: strong ability to solve complex problems with a strategic, forward-thinking approach Regulatory Knowledge: deep understanding of global clinical trial regulations (including IVDR and FDA) and best practices in clinical operations Innovation: passionate about bringing external expertise in-house to drive new product developments and innovative study designs The expected salary range for this fully remote role is $98,400 to $182,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits 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. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.