Sr. Clinical Research Lead

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职位

Job Summary:

1. This position provides strategic guidance, oversight, and effective delivery for clinical programs in areas of focus in partnership with cross-functional key stakeholders involved in clinical development.

2. 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 NMPA and/or international requirements and/or best practices.

3. Be familiar with regulatory requirements and understand regulatory trends and the impact on the project.

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

5. 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.

6. Expertise in clinical pathways and performance metrics; skilled in the independent development of rigorous clinical study reports and academic publications.

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

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 insisting on long-term strategies.

11. Identify opportunities of cost reduction from a functional team perspective to maximize cost effectiveness.

12. Provide support, motivate and inspire others to perform at their best performance.

Main Tasks & Responsibilities:

1. Plans and executes local studies includes clinical evaluation, clinical trials and/or other 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 a larger area(s) budget.

5. Manages the trial budgets and timelines and is accountable for ensuring that budgets and schedules are met.

6. Manages internal and external resources to make studies succeed.

7. Skilled in using clinical strategies and performance specs to develop rigorous study reports and high-level academic literature.

8. Build up a team and identify the advantages of team members, promote the cooperation of team members advantages. Ensure that the goals and activities of your work or project team are aligned with regional and company goals. And discover the needs of team members in solving problems, and guide them to better understand and solve problems correctly.

9. Build up effective communication methods to manage project members/teams and support and motivate others to perform at their best.

10. Ensures direct reports have the proper materials, systems access and training to complete job responsibilities and are in compliance with regulations, SOPs and protocols.

11. Provides technical expertise to staff for feasibility assessment support to review and approve the 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.

12. Maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners in meeting business goals and ensuring operational excellence.

13. 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.

14. Manages relationships with key opinion leaders, laboratory chiefs, investigators and key customers.

15. Regularly interacts with executive management on work of area(s) that impacts larger organizational goals.

16. Responsible for establishing plans for the area with input from more senior management.

17. If applied, be a contact window, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects.

18. Conduct Other tasks assigned by the line manager.

19. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.

20. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).

Basic Requirements of the Job:

Education& Qualifications:

1. At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology

2. Proficiency in English language skills

3. Good command of MS office software application

4. Understand medical device (including IVD) regulations and medical device GCP.

Experience:

1. Minimum of 10 years' experience in clinical research, or clinical development, within the pharmaceutical, medical device, in-vitro diagnostics (IVD), or CRO industries.

2. Two-three years of people management experience is a plus but not prerequisite.

3. Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.

4. Have the capacity to resolve complex problems through in-depth evaluation of various factors

5. Resolve conflicts constructively from the perspective of all stakeholders

6. Have the capacity to identify and gain support from others to achieve recognition and solutions

7. Have the capacity to communicate and coordinate with multi-functional team

Travel Requirements:

1. Approximately 20% of time local and/or international travel.

我们是谁

打造更健康的未来是促使我们创新的动力。全球超过100,000名员工共同致力于推进科学，确保今天和明天的人们，都能获得高质量的医疗资源。我们的努力帮助了2600多万人使用我们的药物进行治疗，我们的诊断产品运行超过300亿次检测。罗氏通过赋能探索新的可能、激发创造力并保持高标准以提供突破传统的医疗解决方案，对全球的医疗环境带去推动和影响。

让我们一起，构建更健康的未来。

罗氏提供平等的职业发展机会。