You will be responsible for:
- 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.
- 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.
- Provides input to budgets. Identifies opportunities to reduce costs. May manage portions of larger area(s) budget.
- Manages the trial budgets and timelines and accountable for ensuring that budgets and schedules are met.
- Manages internal and external resources to support scheduled studies.
- Ensures direct reports has the proper materials, systems access and training to complete job responsibilities and are in compliance with regulations, SOPs and protocols.
- 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.
- 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 Roche Diagnostics 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
- Conduct Other projects or tasks assigned by line manager
- 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
- Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook)
You should have:
- At least Bachelor degree in medical science, preferably in clinical medicine, medical laboratory, biochemistry, pharmacology, bio-engineering and biology
- Proficiency in English language skills
- Good command of MS office software application
- Understand pharmaceutical and/or medical device regulation and ICH/GCP
- At least 8 years of working experience in clinical research, clinical project management, data management in clinical medicine, CRO, pharmaceutical, Medical Device, or in-vitro Diagnostics industries.
- Two-three years of project management or people management experience is a plus but not prerequisite.
- Effective oral and written communication skills; able to get ideas across face-to-face, in group settings as well as in presentation.
- Approximately 20% of time local and/or international travel.
罗氏是一家提供均等机会的雇主。Research & Development、 Research & Development > Clinical Operations