Clinical Project Lead (Continuous Glucose Monitoring)

Position Overview

We are looking for a dynamic and experienced Clinical Project Lead (internally known as a Global Study Lead) to join our Clinical Development & Medical Affairs (CDMA) team at Roche Diagnostics Solutions (RDS). In this pivotal role, you will lead global study teams to ensure the successful execution of clinical studies, delivering high‑quality study designs, adhering to timelines and budgets, and collaborating with cross‑functional teams to support evidence generation strategies focused on Continuous Glucose Monitoring.

Key Responsibilities

• 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 evidence generation scenarios (e.g., study, real‑world evidence) and coordinate with Regulatory Affairs, R&D, Biostatistics, Data Management, Medical Affairs 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.

Qualifications

• Strong experience in clinical trial management, particularly in the Continuous Glucose Monitoring field.
• Degree in Life Sciences, Healthcare, or a related field; a background in multiple disease areas is a plus.
• 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.
• Excellent ability to explain difficult or sensitive information and build consensus among stakeholders.
• Proven ability to build and maintain relationships with internal teams, external partners, and key stakeholders, including CROs and international opinion leaders.
• Excellent understanding of ISO14155:2026, MDR, and ICH GCP guidelines in the execution of clinical trials.

Roche is an Equal Opportunity Employer.

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