Global Study Lead - Diagnostics (m/f/d)
Publication date:
12 November 2024Workload:
100%- Place of work:Rotkreuz
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. 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. 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 including Pharma partners and service providers including CROs
Who you are
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, personalized healthcare/ companion diagnostics, serology, or pathology/tissue diagnostics
-
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
Ready to take on a role that impacts patients and global healthcare? Apply now to join our collaborative team driving the future of diagnostics!
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche Diagnostics International in Rotkreuz is a leading provider of diagnostic systems solutions, and the largest manufacturer of fully automated in vitro diagnostic systems in Switzerland. We are more than 2’700 passionate colleagues from over 65 nationalities. Find out more about our site in Central Switzerland, here .
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.