Clinical Research Expert/Lead

7 months ago

Shanghai, China Roche Full time

The Position

Job Summary :

1. The person may actively participate on cross-functional project teams responsible for the clinical research activities to support Roche Diagnostic China registration of products developed by Roche Group globally, such as, clinical software, instrument platforms, assays, reagents, devices, instruments, systems and biomarkers. Foster cross functional relationships to create a cooperative work environment in support of corporate goals. Ensures alignment across studies and lifecycle teams with current regulatory expectations including ensures compliance with the company SOPs, Policies, Directives, Divisional standards, Declaration of Helsinki, Industry standards, relevant GxPs, both CNMPA and/or international requirements and/or best practices. 

2. Be the expert and scientist in diagnosis and treatment, skilled in protocol design.

3. Be familiar with regulatory requirements, understand regulatory trends and the impact on the project, has the capability of policy-shaping.

4. Identify opportunities to simplify and speed up the institution, EC and HGRAC application process. 

5. Be familiar with company and department policies/department regulations and SOPs and understand the business relationships, and have the capacity to innovate.

6. Be familiar with the product characteristics, guidance and consensus of relevant experts in the field of the research project, and provide key suggestions for the protocol design.

7. Provide strategies for clinical studies, including clinical evaluation, clinical trials and/or other clinical project.

8. Identify new risks in a changing environment and effectively identify and control risks.

9. Adjust clinical plan according to changes and trends.

10. Adapt to volatile environments while insist to focus on long-term strategies.

Main Tasks & Responsibilities :

1. Plans and executes local studies includes clinical evaluation, clinical trials and/or research studies primarily for non-approved product registration in China and/or may support regulatory registration elsewhere.

2. Responsible for the implementation and support maintenance of the clinical trial-related policies, as well as processes and procedures related to the Design Control requirements.

3. Deliver clearly goals, deadlines and expectations to ensure the project is achieved
4. Provides input to budgets. Identifies opportunities to reduce costs. May manage portions of larger area(s) budget.

5. Manages the trial budgets and timelines and accountable for ensuring that budgets and schedules are met. 
6. Manages internal and external resources to make studies succeed. 
7. Build up effective communication methods to manage remote project members/teams and support and motivate others to perform at their best.
8. Develop and maintain test materials and equipment management plan, and conduct maintenance and management.
9. Provides technical expertise to staff for feasibility assessment review and the development of clinical trial documents， IT systems and records (protocols, ICF, data collection forms/plans/reports, monitoring plans, manual of operations, investigator training materials, clinical trials report, study forms, templates and monitoring reports, etc.) and trial conduct (oversee central archiving, study supply management, regulatory submissions and CAPA effectiveness, vendor selection). Provides clinical operation SOP review and expertise. 
10. Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensure operational excellence. 
11. Acts as liaison and/or subject matter expert with multiple groups within Roche Diagnostics divisions and other partners to identify, scheduling and implement collaborative studies, regulatory activities, and other programs. 
12. Manages relationships with key opinion leaders, laboratory chiefs, investigators and key customers. 
13. Regularly interacts with executive management on work of area(s) that impacts larger organizational goals. 
14. Responsible for establishing plans for area with input from more senior management. 
15. Be a

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