项目管理助理 / Project Management Assistant

该职位来源于猎聘 工作职责： A. 项目支持/Project Support: 1. 协助项目团队组织会议、记录会议纪要并跟进行动项。 Support project team by organizing meetings, documenting minutes, and tracking action items. 2. 协助准备和审核临床试验相关文件，如研究方案、病例报告表和研究报告等。 Assist in the preparation and review of clinical trial-related documents, such as protocols, case report forms, and study reports. 3. 与CRA及跨职能团队就项目相关事务进行沟通协调。 Communicate with CRAs and cross-functional team on project related matters. 4. 按照TMF索引要求，及时更新试验主文件(TMF)，归档项目相关文件及往来沟通记录。 Maintain Trial Master Files (TMF) updated, filing project related documents and corresponding communication into TMF as per TMF index. 5. 及时更新临床试验管理系统(CTMS)。 Maintain CTMS updated. B. 数据管理/Data Management: 1. 协助数据管理团队进行数据清理、验证及整合工作。 Support the data management team by assisting in data cleaning, validation, and integration. 2. 确保数据的准确性和完整性，符合公司及监管机构的相关要求。 Ensure data accuracy and completeness, following company and regulatory requirements. 3. 定期检查eCRF，并向项目经理(PM)提供所需信息。 Regularly check eCRF and provide Project Manager (PM) with required information. C. 法规事务/Regulatory Affairs: 1.协助准备法规相关文件及递交材料，包括与伦理委员会及监管机构的沟通。 Assist in preparing regulatory documents and submissions, including communications with ethics committees and regulatory authorities. 2. 确保项目遵循相关法规和指导原则，包括GCP和ICH相关要求。 Ensure projects comply with relevant regulations and guidelines, including GCP and ICH requirements. D. 团队写作/Team Collaboration: 1. 与临床运营、数据管理、医学撰写及法规事务等跨职能团队密切合作。 Collaborate with cross-functional teams, including clinical operations, data management, medical writing, and regulatory affairs teams. 2. 积极参与项目会议，提供必要的支持与建议。 Actively participate in project meetings and provide necessary support and input. 工作要求 1. 临床医学、生物医学或相关专业本科及以上学历。 Bachelor's degree or above in clinical medicine, biomedical sciences, or a related field. 2. 优秀的英文能力。 Fluent in English (both spoken and written). 3. 对临床试验流程有基本的了解，熟悉 GCP 和 ICH 指南。 Basic understanding of clinical trial processes, familiarity with GCP and ICH guidelines.

• 有 CRO 或临床试验项目管理经验者优先。 Applicants with experience in CRO or clinical trial project management are preferred