Clinical Research Lead

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

• →Plans and executes local studies includes clinical evaluation, clinical trials and/or research studies primarily for non-approved product registration in China, ensures all clinical studies 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.  
• →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.    
• →Deliver clearly goals, deadlines and expectations to ensure the project is achieved.
• →Provides input to budgets. Identifies opportunities to reduce costs. May manage portions of larger area(s) budget. 
• →Support to manages the trial budgets and timelines and accountable for ensuring that budgets and schedules are met. 
• →Manages internal and external resources to make studies succeed. 
• →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.
• →Build up effective communication methods to manage project members/teams and support and motivate others to perform at their best.
• →Ensures direct reports has the proper materials, systems access and training to complete job responsibilities and are in compliance with regulations, SOPs and protocols.
• → Develop and maintain test materials and equipment management plan, and conduct maintenance and management.
• →Provides technical expertise to staff for feasibility assessment ，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.
• →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. 
• →Acts as liaison and/or subject matter expert with multiple groups within company divisions and other partners to identify, scheduling and implement collaborative studies, regulatory activities, and other programs. 
• →Manages relationships with key opinion leaders, laboratory chiefs, investigators and key customers. 
• →Regularly interacts with executive management on work of area(s) that impacts larger organizational goals. 。
• →Responsible for establishing plans for area with input from more senior management. 
• →If apply, be a contact window, develop and maintain a good working relationship with BAs and other dept. to support the cross-functional projects.

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 pharmaceutical and/or medical device regulation and ICH/GCP

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.