Syneos FSP Clinical Operation Quality Lead 临床质量管理

该职位来源于猎聘 FSP Global MNC Pharma Location: 上海市静安区南京西路越洋广场

Position title: Clinical Quality Manager 临床质量管理QC

工作内容:

• 负责临床项目的质量控制管理,按照计划完成核查准备和现场支持工作,制定质控计划并实施
• 负责项目质量问题的汇总分析,同项目管理团队一同讨论制定预防和纠正措施
• 向临床部门提供法规和SOP的培训

招聘要求

• 统招本科及以上学历
• 5年以上CRA经验,1年以上临床质控相关经验优先
• 具有国家局核查经验的1年以上Lead CRA
• Global CRO/pharma工作经验优先
• 了解当地法规要求,具有CFDI/FDA等核查经验优先
• 良好的沟通能力和执行能力,能有效的与跨职能团队合作,流利的英文听说读写能力

Basic purpose of the job* As a member of clinical operations quality team in TCM, to drive quality initiatives in assigned area to better ensure inspection readiness and fulfill required duties for inspection readiness activities Accountabilities*

• As part of the TCM CO Quality team, be responsible for the quality initiatives in assigned area, this will not include but not limited to:
• Implement global and local quality initiatives within the TCM CO
• Participate, support and actively contributes to continuous process improvements, knowledge management and training management within CO, when applicable
• Work closely with QM team to identify areas for quality improvements and discuss suggestions; support CO to plan/strategize quality initiatives and ensure implementation
• Inspection Readiness
• Perform required tasks according to the inspection readiness plan including perform on site visit, in house TMF review, organize regular meetings, etc.
• Work closely with CTMs within TCM CO to ensure inspection readiness plan is implemented for the assigned trials.
• Familiarize with assigned trials for inspection readiness and lead/coordinate inspection readiness activities for the assigned trials.
• Collate progress / status report of inspection readiness preparation activities for assigned trials and communicate such status / progress to stakeholders
• Support CTMs to ensure gaps identified during inspection readiness are appropriately addressed
• Collaborate with QM colleague to perform trend /GAP analysis for the trials that undergo inspection readiness, if required; and work with trial team to develop preventative measurements; to ensure preventative measurements are implemented
• Quality Management
• Perform QC visits as delegated by CTM to determine if the trial conducting and clinical monitoring done by CRA is in compliance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP and all applicable regulations to ensure that the rights and well-being of the patients are protected and that the study data are accurate and reliable
• QC visit both conduct in-house and on-site, review of safety information, review of facilities, and review of CRFs and source documentation
• Complete QC visit report, ensure observations from such visits are properly addressed
• Follow-up on QC visit/site issue review/CTMF review/audit/inspection issues as well as corrective action and preventive action (CAPA) with CRA and CTM
• Assist the CTM in the relevant activities and tasks in relation to audit and inspection preparation as well as logistic including in the review and response to audit/inspection queries as well as any audit/inspection reports Minimum Education/Degree Requirements* Bachelor Degree in Life Sciences, preferably in Medicine, Pharmacy or Health Sciences. Required Capabilities (Skills, Experience, Competencies)*
• Minimum 5 years' experience in clinical operations, including at least 1 year quality relevant experience
• Project management experience or equivalence will be a plus
• Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical trials
• Strong Quality sense and proven records of high-quality standard
• Good communication and organization skills
• Fluent in reading, writing and speaking English
• Willing to travel Syneos Health赛纽仕医药是一家全面整合生物制药解决方案的公司,旨在帮助客户加快推出新疗法的速度。我们站在产品研发的角度,战略性地融合临床研发、医学事务和商业能力,以及时应对最新市场变化。

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