Location: Shanghai
Job Type: Onsite, Full-time employee
Reporting to: CSO

Job Purpose:
Lead execution of local or global clinical studies within budget and in accordance with established timelines and quality standards.

Responsibilities:
-Builds a high efficient clinical operation team
-Ensures clinical trial projects are properly resourced, managed and executed.
-Plans and executes project management activities for assigned studies including timelines, risk assessment, mitigation plans, recruitment proposal and plan，and other aspects of clinical study project management (e.g. budget, metrics).
-Key document preparation and review (protocols, IBs, CSRs, etc).
-Leads study team meetings with internal cross functions and external vendors.
-Ensures clinical study sites activation within agreed timeframe.
- Timely identifies trends and issues within/across assigned trial(s) which may impact key deliverables (e.g. timelines/quality/costs) and implement action plans to either resolve and/or mitigate those.
-Manages clinical study teams/CRO to ensure the trials can be completed on time, within budget and in compliance with regulations.
-Designes, updates and implements appropriate procedures related to clinical study development.
-Develops study training and may also coordinate/deliver training, as appropriate.
-Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.
-Maintains and archives at trial level documentation.

Qualifications:
-Education: Master or doctoral degree in Medicine, Pharmacy, Biology, Immunology，or a related field.
-At least 7 years of experience in the pharmaceutical industry, at least 5 years direct experience in planning and managing clinical trials.
-The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials.
-Fluency in English and Chinese language (written and spoken) as well as strong communication skills.
-The candidate should be goal-oriented, a self-starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
- Serves as best practice resource within clinical operation; may also act as a technical expert on cross-functional teams or projects.

其他信息
语言要求：英语、普通话

所属部门：临床部