Key work:
Responsible for animal trial project of AH pharmaceutical and biological products.Support GP person for CRO resourcing and contractual agreements. Collaborate with legal, compliance colleagues to manage contract procedure and other tasks according to SOP.Lead for clinical trial project kick off. Organizing study protocol discussion, collecting comments from CRO, PM, GRA, and global R&D, finalize protocol. Submit and get clinical trial notification according to CN regulation.In charge of project quality management, carry out monitoring, communicate with CRO&PM regularly, ensure study completed within planned timeline.Reviewing study report, assist CRO to finalize after all comments from PM and global team resolved.Other tasks: apply for payment according to payment plan behind contract, update and learning clinical trial regulation, timely archive documents for each project, other tasks assigned by supervisor.
Requirement:
Education: master’s degree or above. Major in veterinary medicine, veterinary pharmacological, or relevant.
Experience: 3-5 years of clinical trial or R&D experience on pharm and bio products.
Skills, abilities, and others:
- Super familiar with GCP regulation and tasks of each stage for clinical research, carry out good quality and schedule management of the project.
- Proficient in oral and written English.
- Good communication skills.
- Strong logical thinking and time management ability.