北京招聘

工作内容：

• 负责协调管理项目准备，启动，实施及结束等各项工作；

• 与客户在项目在阶段保持良好沟通并有向临床研究团队及客户双方效传递需求；

• 负责跟进临床试验进度、相关文件及报告的状态、风险和时间管理；

• 负责管理在项目团队中CRA及项目协调员的工作

任职资格:

• 本科以上学历，临床医学及相关专业；

• 在制药企业或CRO公司至少5年以上临床研究相关工作经验，2年以上临床试验管理的工作经验并至少完整经历过一个临床试验的整个进程；

• 能熟练使用英语沟通；

• 积极主动、善于沟通、协作，具有良好的团队合作精神；

• 国际项目经验者优先考虑。

Responsibilities:

• Coordinate and manage project start-up, project maintenance, and project close-out activities;

• Maintain ongoing Sponsor contact for project-specific issues by serving as primary contact for Sponsor and all project team members; 

• Track study status including patient status, Case Report Form status, safety issues, timelines, etc.;

• Serve as primary contact for protocol interpretations and logistical project related issues (internal and external);

• Provide management oversight for Clinical Research Associates and Project Coordinators on project team;

• Interpret contract-related issues and coordinate Medpace activities according to current scope;

• Develop study management tools, including communication plan, clinical monitoring plan, patient recruitment and retention plan;

• Communicate change in scope to Sponsor clinical team and Medpace Contract Manager. 

 

Qualifications:

• Bachelor’s degree and 5 years related pharmaceutical industry experience (clinical monitoring or study management)

• Broad knowledge of medical terminology, clinical patient management, and clinical research methodology; 

• Demonstrate appropriate judgment in making decisions/seeking supervisor support;

• Ability to understand and present relevant clinical data and handle protocol-related questions; 

• Effectively coordinate and understand project team members’ functions and communicate with Sponsor;

• Provide project-specific oversight of Clinical Research Associates, Project Coordinators, and Clinical Trial Assistants;

• Demonstrate measurable knowledge of Good Clinical Practice (GCP) requirements and local regulations for conducting clinical trials; and;

• Proficient knowledge of Microsoft® Office software.

北京MEDOACE医药科技有限公司是一家美资独资在全球排名前十的CRO 公司，主要为欧美及亚太地区的新药上市提供临床监察，注册，数据统计及实验室服务。公司总部设立在美国俄亥俄州的辛辛那提，全球有超过4500名员工分布在28个国家。