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The Position
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
We are looking for a dynamic and experienced Global Study Lead to join our team. In this pivotal role, you will lead global study teams to ensure the successful execution of clinical studies. You will be responsible for delivering high-quality study designs, adhering to timelines and budgets, and collaborating with cross-functional teams to support evidence generation strategies.
If you have a passion for advancing clinical trials in the cardiovascular/metabolic area, specifically in Near Patient Care, we would love to hear from you!
Key Responsibilities:
1. Lead and oversee the global study team, ensuring full accountability for study deliverables including quality, budget, and timelines.
2. Collaborate with Program Leadership to prepare different scenarios for evidence generation (e.g., study, real-world evidence) and ensure cross-functional cooperation with Regulatory Affairs, R&D, and CDMA Project Teams.
3. Develop key study documents such as Design Validation Plans, study protocols, training materials, study forms, templates, and study reports.
4. Maintain responsibility for the study-level budget of assigned studies.
5. Ensure compliance with regulations, guidelines, and standard operating procedures, while ensuring audit/inspection readiness.
6. Oversee execution of sponsored studies for registrational and non-registrational purposes through all study phases (planning, start-up, conduct, and close-out).
7. Manage study activities outsourced to service providers, including CROs, ensuring timely and quality execution.
8. Work with the Publication Team to ensure study results are effectively published.
9. Track project performance and ensure that projects are completed on time, within scope, and within budget.
10. Build and maintain strong, collaborative relationships with internal and external stakeholders, including cross-functional teams, CROs, opinion leaders, investigators, and key customers.
Your Profile:
1. Strong experience in clinical trial management, particularly in the cardiovascular/metabolic indication and Near Patient Care. Experience with studies in an emergency department setting is a plus.
2. You have a degree in Life Sciences, Healthcare, or a related field. A background in multiple disease areas is a plus.
3. You have practical knowledge of clinical trial management and product development, with a solid understanding of Clinical Operations.
4. Ability to lead and manage projects and provide guidance to less experienced colleagues.
5. Strong analytical skills to solve complex problems and provide innovative solutions.
6. You're able to explain difficult or sensitive information and build consensus among stakeholders.
7. You have a proven ability to build and maintain relationships with internal teams, external partners, and key stakeholders, including CROs and international opinion leaders.
This role is open in the UK, and in Germany Penzberg.
If you’re looking to make a significant impact in a leading global healthcare organisation and have the required experience and qualifications, we invite you to apply today.
Please upload only your current compelling CV and/or Cover Letter. We look forward to receiving your application!
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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 at Penzberg, near Munich, employs more than 7,000 people. The site is one of the largest biotechnology centers in Europe and the only Roche site with research, development and production for both Pharmaceuticals and Diagnostics under one roof. From your beginning with Roche, our motivated team will welcome and support you. Numerous opportunities for personal development, flexible work hours, attractive compensation packages and special family assistance programs are available.
Roche is an Equal Opportunity Employer.
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