岗位描述：

Job description:

1. 撰写和签署试验方案/方案修订；

Writing Study Plan/Amendments and approve them.

2. 确保在试验启动前，实施过程中与质量保证人员进行有效的交流和沟通，及时处理质量保证部门提出的问题和建议；

To insure a good communication with QA staff prior to study start until study completed and handling/respond QA finding in a timely manner.

3. 确保参与研究专题的工作人员方便获得试验方案、方案修订和相应的SOP；

To ensure every study staffs/responsible scientists acquire study plan, amendment and relevant SOP conveniently.

4. 组织方案讨论、学习、及时召集相关人员进行所负责项目的阶段进展讨论，并通报给部门负责人；

SD is responsible to organize pre-study meeting/discussion and monitoring study phase and then report to Department Head.

5. 确保试验方案在试验实施过程中被严格执行，记录试验过程中出现任何偏离试验方案的异常情况，并评估其对试验质量和完整性造成的影响，必要时采取适当的纠正措施。确认试验实施过程中是否有对SOP的偏离情况，必要时进行评估；

To document any deviations including SOP deviations caused during study and to make assessment for any impact to study integrity. To take appropriate corrective action when necessary.

6. 掌握研究工作的进展，检查各种实验记录，确保其及时、直接、准确和清楚地进行了记录；

SD will be responsible to control the study process, inspecting and monitoring all related test record, to guarantee the integrity and accuracy of the records

7. 确保试验过程中试验的计算机系统/实验仪器经过验证；

To guarantee the computerized system and laboratory instruments/apparatus used in each study are validated and qualified.

8. 及时与主要研究者（PI）及其他相关人员进行沟通和协商，以促进试验的顺利进展；

To communicate with PI and other related personnel to promote the study process successfully.

9. 撰写并签署总结报告，评估试验实施过程中GLP的遵循情况；

To write and approve the final report in compliance with GLP in GLP study.

10. 实验结束后，确保将实验方案、原始资料、应保存的标本、各种有关记录文件和总结报告等归档保存；

To ensure Study Plan, Raw Data, Sample, all related file and Final Report were archived after the study was closed.

11. 执行SOPs的规定，及时提出修订或补充相应SOPs的建议

Following SOPs and provide valuable suggestion for SOPs revise.

任职资格：

Qualification:

l 硕士或以上学历，4年以上毒理、药理、病理等相关领域工作经验；

Master degree or above, at least 4 years work experience in toxicology, pharmacology, pathology or related area.

l 4年以上的GLP相关工作经验，熟悉CFDA/FDA/OECD对于试验的要求。能够独立设计、指导、操作试验，并书写报告；

At least 4 years GLP related work experience, familiar with study requirements from CFDA/FDA/OECD. Be capable of designing directing and operating the study, and composing report independently.

l 工作严谨、认真负责，具有原则性强、沟通力强、良好的职业道德和团队意识；

Work in an elaborate and responsible way. Be a good team player with excellent professional ethics and communication skill.

l 流利的英文沟通能力（书面英语和英语口语）

Communicating with English fluently (Oral and Writing English)

上班地址：上海市浦东新区海科路501号