Global Study Lead, Core Lab CVMD in Burgess Hill

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.

We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life.

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 disease area (CVMD), specifically in Core Lab SWA (Serum Work Area) Systems and Automation, we would love to hear from you!

• Lead and oversee the global study team, ensuring full accountability for study deliverables including quality, budget, and timelines.
• 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, Biostatistics, Data Management and CDMA Project Teams.
• Develop key study documents such as Design Validation Plans, study protocols, training materials, study forms, templates, and study reports.
• Maintain responsibility for the study-level budget of assigned studies.
• Ensure compliance with regulations, guidelines, and standard operating procedures, while ensuring audit/inspection readiness.
• Oversee execution of sponsored studies for registrational and non-registrational purposes through all study phases (planning, start-up, conduct, and close-out).
• Manage study activities outsourced to service providers, including CROs, ensuring timely and quality execution.
• Work with the Publication Team to ensure study results are effectively published.
• Track project performance and ensure that projects are completed on time, within scope, and within budget.
• Build and maintain strong, collaborative relationships with internal and external stakeholders, including cross-functional teams, CROs, opinion leaders, investigators, and key customers.

• Strong experience in clinical trial management, particularly in the cardiovascular/metabolic indication. Experience with IVD clinical and analytical system studies in the Core Lab Serum Work Area setting is a plus.
• You have a degree in Life Sciences, Healthcare, or a related field. A background in multiple disease areas is a plus.
• You have practical knowledge of clinical trial management and product development, with a solid understanding of Clinical Operations.
• Ability to lead and manage projects and provide guidance to less experienced colleagues.
• Strong analytical skills to solve complex problems and provide innovative solutions.
• You're able to explain difficult or sensitive information and build consensus among stakeholders.
• You have a proven ability to build and maintain relationships with internal teams, external partners, and key stakeholders, including CROs and international opinion leaders.

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!