Clinical Operation (Associate) Manager
百济神州(北京)生物科技有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-08-05
- 工作地点:北京-朝阳区
- 招聘人数:2人
- 工作经验:无工作经验
- 学历要求:招2人
- 语言要求:不限
- 职位月薪:2.5-3万/月
- 职位类别:生物工程/生物制药
职位描述
Major Responsibilities
· Participates in clinical trial scenario planning (estimates timeline and cost, requests internal resources) · Works with Strategic resourcing team to select study vendors · Oversees study vendors to ensure quality and delivery · Oversees the development of and adherence to clinical trial project timelines · Ensures senior Clinical Operation staff, DCT, and line function heads are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks · Coordinates the relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection) with other BeiGene functions (primarily those represented on CST) to support clinical trials delivery within the drug development process · Ensures study plans (including but not limited to project plan, communication plan, issue escalation plan, clinical monitoring plan, medical monitoring plan, drug safety monitoring plan, data monitoring plan, Trial Master File plan and etc) are created, updated and distributed timely · Coordinates with Clinical Supply Chain regarding drug forecasting and supply of drug products to sites · Ensures site monitoring reports are accurate and reviewed on a regular basis · Closely monitors Case Report Form (CRF) data entry and source document verification (SDV) status · Ensures that Trial Master File (TMF) for assigned clinical trial(s) is created, maintained, QC checked and complete on a timely basis · Reviews trial scope, budget and change orders. Adheres to clinical trial budgeting process and provides input to finance on budget accruals and forecasts · Adheres to and contributes to the development and review of Clinical Operations Work Instructions and SOPs, if required
Qualification
· Bachelors degree or higher in a scientific or healthcare discipline preferred · 5 years or above of progressive experience in clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field · Documented training, knowledge and application of current FDA Regulations, GCP and ICH guidelines in clinical trials required · Management experience of CROs and other Vendors preferred · Therapeutic or medical knowledge preferred · Experience developing trial plans including project plan, site monitoring, pharmacy and lab manuals, risk mitigation strategies, trial budgets and site selection/feasibility as required. · Exhibits a strong understanding of methodologies and approaches · Strong written and verbal communication skills
职能类别: 生物工程/生物制药
公司介绍
联系方式
- Email:shan.liu@beigene.com
- 公司地址:昌平区生命科学园 (邮编:102206)