北京招聘

职位描述：
Zai Lab (www.zailaboratory.com) is a leading biotech company based in Shanghai Zhangjiang Hi-tech park. The company focuses on developing novel medicines with unmet medical needs for patients around the world. Zai Lab is committed to build a globally leading drug development powerhouse with a culture of excellence and team work, and a strong focus on fostering innovation and creativity.

Major Responsibilities and Duties::
1) Plans and executes trial level project management activities for assigned studies including trial level timelines, risk assessment, mitigation plans, and other aspects of trial level project management (e.g. budget, metrics).
2) Leads study team meetings.
3) Develops and tracks overall trial timeline and gains alignment with affiliates and team members on milestone dates.
4) Ensures data compliance at the trial level to achieve country and site level compliance, as appropriate.
5) Manages relationships and serves as the focal point of communication between internal and external clinical research partner at the trial level.
6) Productively identifies and communicates appropriately the status of ongoing projects, Issues, and risks that may affect the critical path of the clinical trial and project schedule.
7) Reviews sourcing alternatives, provides necessary study specific actions in order to obtain reliable study costs, staffing strategy, and timeline projections.
8) Provides oversight of CRO performance throughout study implementation.
9) Develops study training and may also coordinate/deliver training, as appropriate.
10) Obtains clinical trial cost forecasts. Establishes and monitors the trial budget.
11) Manages and tracks trial enrollment.
12) Coordinates proposal reviews with third party vendors, and provides input regarding needed changes in contract conditions.
13) Anticipates, manages, and escalates Issues as appropriate.
14) Maintains and archives at trial level documentation.
15) Partners with study team in the management of data locks (final and interim) and site closure.

Qualifications:
1) Bachelor's degree in a scientific or health related field.
2) 5+ years clinical research or relevant experience, phase III oncology trial experience preferred.
3) Comprehensive understanding of Good Clinical Practices, Good Documentation Practices, CFDA regulations.
4) Excellent interpersonal skills and demonstrated business acumen with an ability to interface successfully with physicians and their staff, executive management, and cross-functional teams and individuals.
5) Excellent verbal and written communication skills.
6) Excellent office computer skills, including experience with clinical databases.
7) Effective cross-functional team player with ability to work in a team environment.
8) Demonstrated leadership skills.
9) Excellent project management and organizational skills; able to handle multiple tasks/projects and manage priorities accordingly; with a high tolerance for ambiguity. 举报 分享

Zai Lab is an innovative biopharmaceutical company based in Zhang Jiang, Shanghai focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab focus on innovation to meets the unmet medical needs. Zai has built up a strong pipeline with multiple programs on clinical stages. Zai Lab successfully listed on Nasdaq in Sep. 2017.

再鼎医药是一家总部设立于上海张江，致力于研究、开发和销售创新药物的制药企业。再鼎医药针对目前尚无良好治疗手段的疾病领域开发新药，在肿瘤、抗感染、自身免疫等方面建立了全面的产品线，服务中国和全球病患。再鼎医药于2017年9月在美国纳斯达克成功上市。