Global Clinical Operations Excellence Leader Medical Devices & Digital Health
Basel - Switzerland
Job Summary
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.
As a Global Clinical Operations Excellence Leader you will play a pivotal role in driving enterprise-wide improvements and transforming clinical trial delivery across medical devices and digital health this strategic role you will establish industry-leading processes and frameworks that ensure inspection readiness and set new standards across the pharma value chain.
Key Responsibilities:
Lead Strategy & Implementation: Architect and execute clinical operations strategies for medical devices and digital health initiatives from Phase I through Phase III studies.
Study Team Strategic Guidance & Support: Provide hands-on strategic direction and operational support to study teams ensuring alignment with project goals and efficient execution.
Establish Operational Frameworks: Design and embed robust processes standards and frameworks that ensure continuous inspection readiness and global regulatory compliance (such as GCP and relevant device regulations).
Drive Portfolio-Wide Productivity: Develop innovative trial execution models and foster collaboration across global cross-functional teams to boost efficiency and trial delivery speed.
Advance Knowledge & AI Integration: Oversee knowledge and learning management strategies integrating modern data tools and AI advancements to support real-time decision-making.
Vendor & Partner Governance: Oversee external research organizations and vendor partnerships establishing governance structures that maintain high quality and operational excellence.
You are a strategic forward-thinking clinical operations expert who thrives in a collaborative fast-paced environment. You are passionate about leveraging technology to improve health outcomes and bring deep hands-on expertise in device trials and digital health solutions.
Qualifications & Experience:
Expert Domain Knowledge: Proven hands-on expertise and strategic experience with medical devices and digital health solutions within clinical trials (Phase IIII).
Regulatory & Compliance Mastery: Deep understanding of regulatory and ISO device regulations strong expertise in establishing compliant processes managing inspection readiness and navigating global regulatory frameworks (such as Good Clinical Practice / GCP).
Operational Excellence & Process Design: Demonstrated ability to build standardize and scale business processes or learning frameworks across complex matrix environments.
Collaborative Leadership: Skilled at influencing cross-functional stakeholders guiding external vendor partnerships and driving strategic initiatives to completion.
Ready to make a difference Together well advance along the whole patient journey with the aspiration to prevent stop and cure diseases.
A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
About Company
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.