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Clinical Trials Lead
2 months ago
Position Overview
Job Summary:
1. The individual will engage in cross-functional project teams dedicated to clinical research initiatives that support the registration of Roche Diagnostic products developed globally. This includes clinical software, instrument platforms, assays, reagents, devices, instruments, systems, and biomarkers. The role emphasizes fostering collaborative relationships to cultivate a productive work environment aligned with corporate objectives. It is essential to ensure compliance with current regulatory expectations, including adherence to company SOPs, policies, directives, divisional standards, the Declaration of Helsinki, industry standards, and relevant GxPs, both CNMPA and/or international requirements.
2. Serve as a knowledgeable expert in diagnosis and treatment, with proficiency in protocol design.
3. Maintain familiarity with regulatory requirements, comprehend regulatory trends, and understand their implications on projects, with the ability to influence policy.
4. Identify opportunities to streamline and expedite the application processes for institutions, EC, and HGRAC.
5. Understand company and departmental policies and regulations, possessing the capacity for innovation within the business context.
6. Be well-versed in product characteristics and relevant expert guidance, providing crucial input for protocol design.
7. Develop strategies for clinical studies, including clinical evaluations, clinical trials, and other clinical projects.
8. Recognize emerging risks in a dynamic environment and effectively manage and mitigate these risks.
9. Adapt clinical plans in response to evolving trends and changes.
10. Thrive in fluctuating environments while maintaining a focus on long-term strategic goals.
Key Responsibilities:
1. Plan and execute local studies, including clinical evaluations, clinical trials, and research studies primarily for non-approved product registration in China, with potential support for regulatory registration in other regions.
2. Oversee the implementation and maintenance of clinical trial-related policies, processes, and procedures related to Design Control requirements.
3. Clearly communicate goals, deadlines, and expectations to ensure project success.
4. Contribute to budget planning, identifying opportunities for cost reduction, and managing portions of larger budget areas.
5. Manage trial budgets and timelines, ensuring adherence to financial and scheduling commitments.
6. Coordinate internal and external resources to facilitate successful study outcomes.
7. Establish effective communication methods to manage remote project teams and inspire peak performance among team members.
8. Develop and maintain a management plan for test materials and equipment, ensuring proper maintenance and oversight.
9. Provide technical guidance to staff for feasibility assessments and the development of clinical trial documentation, IT systems, and records, including protocols, informed consent forms, data collection plans, monitoring plans, and clinical trial reports.
10. Maintain strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and alliance partners to achieve business objectives and ensure operational excellence.
11. Act as a liaison and subject matter expert across multiple groups within Roche Diagnostics and other partners to schedule and implement collaborative studies and regulatory activities.
12. Cultivate relationships with key opinion leaders, laboratory directors, investigators, and primary customers.
13. Regularly engage with executive management regarding work that impacts broader organizational goals.
14. Establish area plans with input from senior management.
15. Contribute to the overall success of the clinical research initiatives.
