Senior Clinical Study Manager-CSMA-上海
施乐辉医用产品国际贸易(上海)有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2019-09-06
- 工作地点:上海-静安区
- 招聘人数:若干人
- 工作经验:无工作经验
- 学历要求:招若干人
- 语言要求:不限
- 职位月薪:4-5万/月
- 职位类别:临床研究员
职位描述
Responsible for the management and execution of clinical studies to ensure the studies are completed within planned budget, timeline, and in accordance with protocol, SOPs and relevant regulations.
Responsibilities: (Please specify % amount against each responsibility)
Develop the overall project plan and assist each CRA in developing the project plan for each site;
Organize the investigators’ meeting for clinical study;
Assist in the protocol design and review of study report;
Select and manage the vendors for clinical studies; monitor the quality of vendor deliverables, address quality issues and identify opportunities to improve training, execution and quality control;
Develop the budget for study supplies and manage the purchase process;
Provide training about protocol, SOPs and guidance to all team members at the study start-up; Evaluate the quality and progress of each team member during the conduct of the study; Assist the CRAs to resolve the issues occurred in the study and make sure the study complete according to the plan;
Coordinate the collaboration among the investigators, monitors, CRCs, data manager & statistician to ensure the successful conduct of the studies;
Maintain good relationship with the principal investigators and each investigation site.
Basic requirement:
Bachelor degree & above in medicine/pharmacy/life science discipline;
At least 5 years’ proven experience in clinical operation with at least 2 years in project management;
Familiar with clinical operation processes/ procedures of whole clinical trial; have good understanding and knowledge of GCP and relevant regulations; familiar with the process and requirement of audit and inspection;
Good in English speaking, reading and writing.
Physical Demands: 健康
职能类别:临床研究员
公司介绍
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
? Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
? Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
? Sports Medicine - minimally invasive surgery of the joint
? Trauma & Extremities - products that help repair broken bones
We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .
联系方式
- Email:Dora.Cui@smith-nephew.comAble
- 公司地址:北京市东城区东中街9号东环广场A座二层B-E号