职位描述

职位描述： Responsibility: • Perform Regular and Ad hoc Quality Review Activities and Analyze Quality Issues o Work with TMF Processing Center Group Leadsand Global TMF Operations to identify the targeted review scope/areas o Create quality review plans, including the resource need, completion timeline, outcome presentation, etc o Perform quality review and take the delegation to assign quality review task to quality management staff and complie the completed review results o Initiate the quality review meeting and finalize the quality review report(s) in a timely manner o Collaborate with global/local SMEs to resolve the queries/questions if needed o Work with Group Lead(s) to review the quality issues and identify the root causes o Perform analysis on the quality review results and propose appropriate corrective/preventive actions o Partner with Group Leads and Global TMF Operations to take the follow-up actions within specific timeline o Ensure the quality review documented and archived appropriately in designated location • Implement Proactive Quality Management Strategy o Work with Group Leads to ensure the required trainings are completed within specific timeline o Collaborate with Global TMF Team Leads to perform TMF knowledge management. i.e. collecting/validating/assembling TMF related knowledge, creating/improving existing guidance, making sure the knowledge is delivered to pertinent stakeholders, etc. o Plan and organize the learning activities related to team’s quality performance • Ensure Compliance o Monitor the training compliance and promptly inform an individual and his/her GL if he/she has non-compliant status. o Maintain the local training record o Create/Revise the Job Description when needed • Provide Business Operations & System Support o Timely report/analyze TMF metrics o Evaluate the effectiveness of task allocation through analysis of productivity, quality (error rate & inconsistency rate) and other indicators (e.g. one-time pass rate), and work with group leads to timely adjust the allocation algorithm when needed. o Watch incoming work volume and plan for overtime, holiday coverage, etc. Work with group leads to ensure the feasibility of the plan. o Provide accurate productivity and quality data of Document Specialists to Group Leads for performance evaluation and improvement o Support resource management through monitoring & analysis on QC/other tasks status (i.e. incoming volume, capability, utilization, etc.) o Participate in developing/improving quality management processes Partner with global system expert to resolve system issues and improve system performance to enhance the effectiveness and efficiency (i.e. UAT, performance testing, change request, etc.) o Maintain public TMF Processing Center sites (i.e. SharePoint site, share disk, knowledge base, etc.) to ensure the relevant information is stored in appropriate location and the functionality meets the business needs Qualification: Training & Education Preferred(ADM02): • Minimum of a Bachelor’s degree or equivalent Prior Experience Preferred(ADM02): • Experienced in ICH-GCP • Effective verbal and written communication skills • Experienced in issue analysis & resolution • Experienced in organizing and conducting learning activities • Experienced in metrics reporting/analysis, system issue resolution and UAT • Experienced in workload and resource management • At least two years working experience in PTMF system 职能类别： 临床数据分析员

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