Job Description
Position Overview
The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In‑Vitro Diagnostics (CEI) team at Roche Diagnostics Solutions (RDS). The role focuses on providing documentation support for a wide range of clinical study documents, including reports, protocols, clinical study reports, investigator brochures, and IVDR performance evaluation documents. The Lead serves as a strategic partner in supporting clinical evidence generation and clinical study design for in‑vitro diagnostics (IVD) registration with regulatory agencies.
Responsibilities
- Design scientifically sound clinical studies in collaboration with subject‑matter experts and other functions.
- Participate in project teams to support study design and execution, including protocol and report generation and critical review of study results.
- Analyze the product portfolio across a specific customer area to create documentation th...