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FSPxGlobal Pharma
工作地点: 上海，静安区，越洋广场
治疗领域: 肿瘤免疫，心肾代谢，中枢神经等

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，制度质控计划并实施
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
向临床运营部门提供法规和SOP的培训

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*

1. 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

2. 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

3. 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)*

1. Minimum 5 years' experience in clinical operations, including at least 1 year quality relevant experience

2. Project management experience or equivalence will be a plus

3. Excellent understanding of ICH GCP, and other applicable regulations, policies related to clinical trials

4. Strong Quality sense and proven records of high-quality standard

5. Good communication and organization skills

6. Fluent in reading, writing and speaking English

7. Willing to travel