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Job title * Clinical Operation Quality Lead 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. 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 2. 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 50%