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工作地點: 上海,靜安寺越洋廣場

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 e.
? 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