职位描述
1.Maintain the LMS e-solution system and support learning management across CRO Business Units and Functions.
维护LMS电子解决方案系统并支持CRO业务部门和职能部门的学习管理。
2.Conceptualize such GCP/GVP/GCLP relevant training, including development of content and evaluation of technical needs for deployment. Develop trainings as requested by and aligned with Business Functions and Process Owners; while adhering to the CRO learning management strategy to ensure the content works properly in learning solution.
概念化类似GCP/GVP/GCLP的相关培训,包括制定内容和评估部署的技术需求。根据业务职能部门和流程负责人的要求开展培训,同时坚持CRO学习管理策略,确保内容在学习解决方案中正常运行。
3.Maintain and continuously learn new methods of content development and to be up-to-date with the changing technology for assigned learning solutions.
维护并持续学习内容开发的新方法,并与所分配的学习解决方案不断变化的技术保持同步。
4.Provide support, consultation, and expertise on specific learning solutions.
为特定的学习解决方案提供支持、咨询和专业知识。
5.Support key procedural documents development and process optimization in collaboration with functional Process Owner and SMEs.
与职能部门流程负责人和SME合作,支持关键规程文件的制定和流程优化。
6.Support audit program establishment for the clinical trials.
支持临床试验稽查程序的建立。
7.Conduct audits of clinical trial sites, labs, computerized systems, vendors, protocols, and study reports and reports all audit observations to clinical sites, functional leadership team and clients, if applicable.
对临床试验研究中心、实验室、计算机系统、供应商、方案和研究报告进行稽查,并将所有稽查结果报告给临床研究中心、职能领导团队和客户(如适用)。
8.Conduct system and process audits as required, e.g. Pharmacovigilance, data management, and safety reporting, etc.
根据需要进行系统和流程稽查,例如药物警戒、数据管理和安全性报告等。
9.Support Computerized System Validation.
支持计算机化系统验证。
10.Support the Client Audits.
支持客户审计。
11.Support inspection Readiness state, local regulatory and health authority inspections as necessary.
必要时支持检查地方监管部门和卫生当局检查前的准备就绪状态。
任职要求:
1.A Bachelor/Master of Science degree in Medicine, Pharmacy, Biology or relevant areas from an accredited college or university
具有医学、药学、生物学或相关领域学士/硕士学位。
2.A minimum of 2-3 years of progressively responsible experience within Clinical Development with at least taking 1 year QC/QA/QMS role.
至少2-3年临床试验相关工作经验,1年以上的QC/QA/QMS岗位经验。
3.Language skill: Excellent English speaking and writing skill is highly preferred.
语言技能:优异的英语口语和书写能力。
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕