• 招聘类型：社招
• 工作性质：全职
• 所属区域：北京 - CBD
• 直属部门：Clinical Operations

职位描述

Plans and conducts on-site and internal QC and compliance checks on project deliverables to verify compliance to GCP, ICH and CFDA Guidelines, BeiGene Controlled Documents (e.g. SOPs), protocol, as well as any BeiGene project specific document requirements. Completes Assessment Reports and presents results of QC and compliance checks to the person assessed, the responsible line manager, recommending corrective actions as necessary, e.g. additional training. Confirms closeout of assessment findings in accordance with stated response times. Initiates escalation of indicated quality events to the Director of Clinical Operation and the responsible line manager. Develops and maintains checklists used during the assessment process (standardization of minimum criteria). Follows up with operational groups on the remediation following QA audits/Regulatory Inspections. Mentors operational staff during the assessment process. Participates in the creation/presentation of training courses based on assessment outcomes. Recommends improvement to training programs.

Plans and conducts on-site and internal QC and compliance checks on project deliverables to verify compliance to GCP, ICH and CFDA Guidelines, BeiGene Controlled Documents (e.g. SOPs), protocol, as well as any BeiGene project specific document requirements. Completes Assessment Reports and presents results of QC and compliance checks to the person assessed, the responsible line manager, recommending corrective actions as necessary, e.g. additional training. Confirms closeout of assessment findings in accordance with stated response times. Initiates escalation of indicated quality events to the Director of Clinical Operation and the responsible line manager. Develops and maintains checklists used during the assessment process (standardization of minimum criteria). Follows up with operational groups on the remediation following QA audits/Regulatory Inspections. Mentors operational staff during the assessment process. Participates in the creation/presentation of training courses based on assessment outcomes. Recommends improvement to training programs.

任职条件

Must have strong knowledge of ICH, CFDA, and GCP regulations and practices. Strong working knowledge of BeiGene SOPs, guidelines, and systems for clinical trial management. Excellent interpersonal, verbal, and written communication skills. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail . Attention to detail and strong organizational skills. Ability to work independently and a flexible attitude with respect to work assignments and new learning .Ability to work effectively in a matrix environment, and to demonstrate and foster teamwork within the group as well as across the entire organization. IT literate – Experience with Microsoft based applications and general knowledge of PC functions. Education:Bachelor’s degree in medical, biological, pharmacy, or health science related field or relevant work experience in clinical research. Language Skill:English and Chinese proficiency .Minimum Work Experience:4+ years of experience in clinical research, inclusive of Lead or Primary experience. Additional experience as a clinical research industry Quality Auditor or Project Manager preferred.

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要