(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:2022-02-07

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.

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