Clinical Research Expert/Lead
1 month ago
Roche is seeking a highly skilled Clinical Research Expert/Lead to support the registration of products developed by Roche Group globally. The ideal candidate will have expertise in clinical research, regulatory requirements, and protocol design.
About the Role
This role involves actively participating on cross-functional project teams responsible for clinical research activities. You will be responsible for fostering cross-functional relationships, ensuring alignment with current regulatory expectations, and compliance with company SOPs and policies. Additionally, you will identify opportunities to simplify and speed up the institution, EC, and HGRAC application process.
Main Responsibilities
You will plan and execute local studies, including clinical evaluation, clinical trials, and/or research studies primarily for non-approved product registration in China and/or may support regulatory registration elsewhere. This role also involves responsible implementation and support maintenance of clinical trial-related policies, processes, and procedures related to Design Control requirements. Furthermore, you will deliver clear goals, deadlines, and expectations to ensure projects are achieved, provide input to budgets, and manage internal and external resources to make studies succeed.
Key Requirements
The successful candidate will have a deep understanding of regulatory requirements, trends, and the impact on projects. You will be skilled in protocol design, familiar with company and department policies, and have the capacity to innovate. Additionally, you will be able to adapt to volatile environments while focusing on long-term strategies. A strong collaborative relationship builder with excellent communication skills is essential for this role. A salary range of $120,000-$180,000 per year reflects the complexity and responsibility of this position.
Benefits
This role offers a comprehensive compensation package, including medical insurance, retirement savings, and paid time off.
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