Clinical Research Specialist

6 days ago

Shanghai, Shanghai, China Roche Full time

Position Overview

Job Summary:

1. The individual will engage in cross-functional project teams tasked with overseeing clinical research initiatives to facilitate Roche Diagnostic China’s product registration for offerings developed by the Roche Group globally, including clinical software, instrument platforms, assays, reagents, devices, instruments, systems, and biomarkers. The role emphasizes fostering interdepartmental relationships to cultivate a collaborative work atmosphere that aligns with corporate objectives. Ensures that all studies and lifecycle teams adhere to current regulatory standards, including compliance with company SOPs, policies, directives, divisional standards, the Declaration of Helsinki, industry standards, and relevant GxPs, whether pertaining to CNMPA or international best practices.

2. Serve as a knowledgeable expert and scientist in diagnostics and treatment, proficient in protocol design.

3. Possess a thorough understanding of regulatory requirements, stay informed on regulatory trends, and comprehend their implications on projects, with the ability to influence policy.

4. Identify avenues to streamline and expedite the application processes for institutions, EC, and HGRAC.

5. Be well-versed in company and departmental policies and regulations, and understand business relationships while demonstrating innovative capabilities.

6. Familiarize oneself with product characteristics, guidance, and consensus from relevant experts in the research domain, providing critical insights for protocol design.

7. Develop strategies for clinical studies, encompassing clinical evaluations, clinical trials, and other clinical projects.

8. Recognize emerging risks in a dynamic environment and effectively manage and mitigate those risks.

9. Adapt clinical plans in response to evolving trends and changes.

10. Thrive in unpredictable 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 aimed at non-approved product registration in China, and may extend support for regulatory registration in other regions.

2. Oversee the implementation and maintenance of clinical trial-related policies, processes, and procedures associated with Design Control requirements.

3. Clearly communicate goals, deadlines, and expectations to ensure project completion.

4. Contribute to budget planning, identifying cost-reduction opportunities, and may manage segments of larger budget areas.

5. Manage trial budgets and timelines, ensuring adherence to financial and scheduling commitments.

6. Coordinate internal and external resources to ensure the success of studies.

7. Establish effective communication strategies to manage remote project teams and encourage optimal performance among team members.

8. Develop and maintain a management plan for test materials and equipment, overseeing their maintenance and management.

9. Provide technical guidance to staff for feasibility assessments and the creation of clinical trial documentation, IT systems, and records (including protocols, ICF, data collection forms/plans/reports, monitoring plans, manuals of operations, investigator training materials, clinical trial reports, study forms, templates, and monitoring reports), as well as trial execution (overseeing central archiving, study supply management, regulatory submissions, and CAPA effectiveness, vendor selection). Offer expertise in clinical operation SOP reviews.

10. Maintain strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners to achieve business objectives and ensure operational excellence.

11. Act as a liaison and/or subject matter expert with various groups within Roche Diagnostics divisions and other partners to identify, schedule, and implement collaborative studies, regulatory activities, and other programs.

12. Manage relationships with key opinion leaders, laboratory heads, investigators, and important customers.

13. Regularly engage with executive management regarding work in areas that impact broader organizational goals.

14. Responsible for formulating plans for the area with input from senior management.

15. Be a proactive contributor to the success of clinical research initiatives.

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