工作简述：
Ø 负责公司将开展的一类新药临床试验项目（肿瘤和自身免疫性疾病）的项目管理工作，进行全面的质量控制和进度管理, 确保项目严格按照GCP、ICH-GCP，SOP，试验方案和中国法律及法规进行。
Ø 根据部门负责人指示, 及项目的临床试验计划, 起草、撰写临床试验相关文件，制定项目管理计划, 确定临床试验进度计划、财务预算等内容, 并在项目进行中不断对项目管理计划进行审核和修改，定期汇报试验进度，完成项目进展报告。
Ø 对所负责的临床试验项目进行访视，督导合同研究组织、临床试验中心按时完成临床试验的全面启动、执行及结束工作。
Ø 在项目过程中识别、监测并及时应对各种风险，正确评估相应风险对项目的整体影响并采取合理的改进措施。
Ø 同主要研究者及合同研究组织保持及时有效的沟通，确保项目相关重要信息被准确完整的传递，培养并保持与中心的良好关系。
Ø 负责对监查员的管理、方案及技能培训，督促监督及管理监查员的工作，并对其进行指导。
Ø 完成公司交代的其他相关工作事务。

Description of work:

Responsible for the project management of the first-class new drug clinical trial projects (tumor and autoimmune diseases) to be carried out by the company, conduct comprehensive quality control and schedule management, and ensure that the project strictly complies with the GCP, ICH-GCP, SOP, trial plan and China Laws and regulations are carried out.

According to the instructions of the department head and the clinical trial plan of the project, draft and write clinical trial related documents, formulate project management plan, determine clinical trial progress plan, financial budget, etc., and constantly review the project management plan during the project And modify, report the test progress regularly, and complete the project progress report.

Conduct visits to the clinical trial projects in charge, and supervise the contract research organization and clinical trial center to complete the full start, implementation and termination of clinical trials on time. Ø Identify, monitor and respond to various risks in a timely manner in the process of the project, correctly assess the overall impact of the corresponding risks on the project, and take reasonable improvement measures.

Maintain timely and effective communication with major researchers and contract research organizations to ensure that important project-related information is accurately and completely transmitted, and cultivate and maintain a good relationship with the center.

Responsible for the management, plan and skill training of the inspectors, supervise and manage the work of the inspectors, and guide them.

Complete other related work tasks assigned by the company.

任职要求：
Ø 医学、临床医学及其相关专业，本科及以上学历；
Ø 从事药物临床研究工作3年以上，具备项目管理技能和经验；
Ø 全面掌握临床试验管理规范和药品管理的相关法律法规；
Ø 具有优秀的问题解决能力及应急预案管理能力；
Ø 责任心强，公平正直，具有良好的沟通能力和协调能力；
Ø 能够承受一定的工作压力，吃苦耐劳，适应经常出差
Ø 熟练操作电脑, 具有熟练的英语听说读写能力

Job requirements:

Medicine, clinical medicine and related majors, bachelor degree or above;

more than 3 years in drug clinical research for, with project management skills and experience;

Fully understanding of the relevant laws and regulations of clinical trial management and drug management;

excellent problem-solving ability and emergency plan management ability;

Strong responsibility, integrity, good communication and coordination skills;

Able to bear a certain degree of work pressure, bear hardships and stand hard work, adapt to frequent business trips

Proficiency in computer operation, with proficient English listening, speaking, reading and writing skills

爱美菲澳洲公司联系信息：

Add: Suite 101 Level 1, 22 Hunter Street, Parramatta, NSW 2150

Tel: 0280061080; 0451806666

Email: seven@augrants.com.au