(高级)临床试验管理助理
公司部门: Clinical Development
工作地点:北京
发布日期:1000-01-01
招聘人数:5人
职位类型:生物制药/医疗器械
职位描述:
主要职能:
1. 协助项目经理管理预算、预提以及付款工作,与CTA及CRA合作以保障付款的及时性与准确性;
Assists PM to develop and coordinate to manage the study budget, accruals and actual cost, coordinate with CTA & CRA ensures study payments are paid on time;
2. 协助项目经理完成试验核心文件的收集、整理、核查和归档;
Assists PM to develop study documents and other materials;
3. 支持及协助项目中供应商的选择工作以及项目进行中供应商的管理;
Coordinates vendor selection (printing, travel agency, etc.) and managements;
4. 纸质文件及电子文件的归档、上传以及文件质量的检查;
Supports TMF related work both paper and electronic Trial Master Files (eTMF), conducts eTMF QC as needed;
5. 协助项目经理组织各种内部会议,如预订会议室,会议纪要的书写等;协助项目组组织研究者会议以及其他项目相关的外部会议;
Assists PM to organize study team meetings, including meeting room booking and setup, meeting minutes taken is required; Provides enough logistic support for investigator meetings;
6. 协助项目经理维护和管理试验相关的系统及账号;
Coordinates with various system accounts applications and managements;
7. 维护和更新试验信息相关数据库、试验相关系统以及试验计划等;
Updates and maintains internal databases, trackers, study related systems and study plans with study specific information;
8. 完成项目经理分配的其他工作;
Undertakes project management activities according to requirements;
9. 为团队的新员工提供相关培训。
Train and coach junior team staffs.
任职条件:
岗位要求:
1. 本科及以上学历,临床医学、英语、行政或相关专业;
Bachelor’s degree and above, majors in clinical medicine, English, Administration and related;
2. 至少2年CTA工作经验,或在相关领域有2年项目管理助理相关经验;
At least has 2 years CTA experience in the Pharmaceutical or CRO industry, or has more than 2 years project management experience in other industry;
3. 良好的英文读写能力;
Proficiency both in local language and English;
4. 熟悉药物临床试验管理规范(GCP)和临床工作相关法规,了解临床研究实施流程;
Familiar with GCP, clinical related regulatory and clinical process.
5. 有良好的工作态度,工作严谨,有责任心,协调沟通能力强,有良好的团队精神与合作意识;
Excellent work attitude and communication skill, conscientious, good team work spirit and corporative.
6. 熟练应用办公软件。
Skilful in office softwares.