CRA South Director

公司部门: Clinical Development

工作地点:上海

发布日期:2022-03-18

招聘人数:1人

职位类型:生物制药/医疗器械

职位描述:

1. 作为CRM和CRA的直线报告对象,负责或协助面试招聘各级别CRA、制订CRA职业发展、技能培训规划、日常管理、月度计划和总结、季度考核及年终考评;

2. 与CRA讨论制定年度考评目标,执行或委托执行新入职CRA监查技能的现场审核监查,执行或委托执行项目质量控制的现场监查;

3. 负责审核CRA的常规培训计划的执行情况,收集CRA反馈,制定或协调制定合适的培训计划并组织常规团队建设;

4. 审核CRA的日常及所负责项目中的经费报销情况,确保报销符合财务相关要求。

Key Objectives/Deliverables:

1. As the direct report object of CRM and CRA, responsible for or help CRA recruitment, creating CRA career development, skills training planning, daily management, monthly plan and summary, quarterly and yearly performance evaluation.

2. Discuss with CRA to set the annual evaluation goals, monitor new CRA monitoring skills test and quality control work;

3. Responsible for reviewing the implementation of CRA routine training program, collect feedback from CRA, make or help to make an appropriate training plan and organize regular team building works;

4. Review CRA's daily and project expense reimbursement to ensure reimbursement complies with relevant financial requirements.

任职条件:

1. 本科及以上学历,护理、医学、药学相关专业;

2. 至少5年以上临床管理相关经验;

3. 熟悉GCP及新药研发流程,精通药品管理有关法规、临床研究监查流程;

4. 熟悉临床研究从立项至研究结束整体流程,熟悉所有类型的临床监查、伦理,递交及合同协商;

5. 良好的亲和力与表达能力,能够与不同背景及能力的人进行有效沟通;

6. 良好的时间管理及工作安排能力,在一定时间内,能适应高强度的工作分配;

7. 良好的写作能力及组织能力,熟练的文献检索能力,能够根据工作要求合理配置资源。

Basic Requirements:

1. Bachelor degree or above, major in Nursing,Medicine, Pharmacy or related;

2. At least 2 years clinical management experience;

3. Familiar with GCP and new drug development process, proficient in drug management regulations, clinical research monitoring process;

4. Familiar with the whole process of clinical research from project approval to study completion, familiar with all types of clinical monitoring, ethics, submission and contract negotiation;

5. Good affinity and presentation skills, able to communicate effectively with people of different backgrounds and abilities;

6. Good time management and work arrangement ability, can adapt to high intensity work assignment within a certain period of time;

7. Good writing and organization skills, proficient in literature retrieval, able to allocate resources according to job requirements.

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