Clinical Operations Quality Lead (FSP)
BEIJING, Beijing, China 职位编号 R0000033657 类别 Quality Management关于这个职位
As part of the Quality team, be responsible for the quality initiatives in assigned area, this will include but not limited to:
a. Implement global and local quality initiatives within the CO(clinical operations)
b. Participate, support and actively contributes to continuous process improvements, knowledge management and training management within CO, when applicable
c. Work closely with QM team to identify areas for quality improvement and discuss suggestions; support CO to plan /strategize quality initiatives and ensure implementation
Inspection Readiness
a. Work closely with CTMs within CO to ensure inspection readiness plan is implemented for the assigned trials
b. Familiarize with assigned trials for inspection readiness and lead/coordinate inspection readiness activities for the assigned trials
c. Collate progress / status report of inspection readiness preparation activities for assigned trials and communicate such status / progress to stakeholders
d. 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. Work with QM and other stakeholders in Medicine to support CTMs and CRAs during a site inspection or sponsor inspection; further more, coordinate certain activities on behalf of clinical operations, if required and appropriate.
4.Take the role of audit response coordinator within CO to ensure all the audit observations are addressed properly within timeline.
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