临床项目研究经理
湛熙企业管理咨询(上海)有限公司
- 公司规模:50-150人
- 公司性质:民营公司
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2019-11-20
- 工作地点:上海-黄浦区
- 招聘人数:1人
- 工作经验:3-4年经验
- 学历要求:招1人
- 语言要求:不限
- 职位月薪:3-4万/月
- 职位类别:临床研究员
职位描述
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.
任职条件
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.
10) Experienced in serving on product development teams and understands the product development lifecycle.
职能类别:临床研究员
公司介绍
在中国服务力量遍布在北京、上海、广州、深圳、成都、南京、宁波、苏州等多个城市, 超过100名专业咨询顾问。
联系方式
- 公司地址:地址:span徐庄路6号