北京招聘

1. INSPECTION SUPPORT

TQM/ TQSM is a key team member to support inspection management and a key contributor to inspection preparation, conduction, and follow-up to ensure a successful outcome. TQM/ TQSM is responsible for internal activities and good compliance with company requirements. This includes, but is not limited to, ensuring the following key areas of focus:

? Organize country level inspection related trainings to preparation team before any onsite activities
? Conduct site level inspection preparation visit to be familiar with site process and observations for inspection supporting purpose. TQSM cooperate with CLM to lead inspection preparation and support activities
? Provide prompt, flexible, high quality support to onsite inspection
? Coordinate and ensure professional response at site and country level

2. QUALITY ENHANCEMENT FOR INSPECTION READINESS

TQM/ TQSM conduct Monitoring Quality Oversight Review visits (MQOR) to spot-check the rights and well-being of human subjects are protected and reported trial data are accurate, complete, and verifiable from source documents, and support the risk signals and issues are identified in a timely manner. TQSM will be assigned as mentor for junior TQM.

TQM/ TQSM conduct eTMF Quality Check in site level, focus on the quality perspective in ongoing base to ensure files are “Ready for Inspection”.

As study quality expert, TQM/ TQSM will be involved in study quality management.
? Cooperate with CLM for ongoing study inspection readiness: Risk detect for local regulation perspective, Quality finding sharing and training
? Base on the support from study audit leader and general, TQM/ TQSM could be copied in all quality related questions and support expansion or follow up check to ensure team’s understanding and execution
? Regular or spot check on site handover documents to ensure team’s compliance and handover quality

TQM/ TQSM centralized support the internal quality data analysis and process improvement.
? Centralized track and analysis of internal and external quality observations, including findings from inspection, Audit, internal CO-visits in the country to determine process and/or efficiency related risks and opportunities. Develops and implements improvements based on the findings if needed.
? Oversight the quality data to detect the potential risks and guide team to perform the deep-dive/root cause analysis to take the appropriate actions timely. Proactively identifies actions to be taken at the site/ country level to improve upon audit and inspection findings

3. SYSTEM MANAGEMENT

TQM/ TQSM, could be assigned as system super user, cover the system management of IMPACT, IRIS, MSTR, RAVE and RBM etc.

? Support SM team members to handle the daily system questions and issues
? Coordinate with global system support team if any complicated issues and training gaps
? Foresee risk from functional perspective via system data analysis
? Provide system trainings or experience sharing if needed

TQM/ TQSM, could be assigned as country metrics champion, Support Site Management Leadership Team to run system data for analysis and support oversee the study business goals status from system.

4. TRAINING MANAGEMENT

TQM/ TQSM is responsible for facilitating the local functional trainings in China. This includes, but is not limited to, ensuring the following key areas of focus:

? New comer training: To organize the training in a quarterly manner to support new comers to be familiar with the organization, local process and practices, LQSDs. Based on the global system training, CQS/CQM train the related systems using local language to enhance the system knowledge
? Office based training: To maintain the routine training platform including Learning day and specific workshops to improve and enhance the daily quality sense for whole team.
? Daily identify the training needs within SM team. Support to filing all the training materials in an ongoing base.

Value added to the success of the company: What are the main objectives of the function?

? There is an increased scrutiny of regulatory authorities on the quality of clinical trial data, and increased business demands to conduct clinical trials in an efficient and reliable manner, the focus of TQM/ TQSM is critical to ensure greater focus on quality and oversight. This helps to enhance the country level oversight for site quality to ensure patient safety as well as quality and compliance of clinical trial data for Regulatory Approvals of a drug. Synergizing with CLMs’ co-monitoring visits (COMO) and LMs’ Monitoring Quality Assessment Visits (MQAV), TQM/ TQSM could be the daily QC staff to identify issues from local inspection view and supervise the issue management process in China. To actively provide adequate quality oversight and timely adjustment in study and site level will lead into a success outcome for inspection.

? TQSM, as a senior role, contributes to lead the inspection preparation and support within SM
? Enrich the quality related position to develop the quality talents within company
? Provide the centralized support to system and training management
        

Work Interactions: List the most important work relationships with internal or external partners / customers.

? TQM/ TQSM works in close collaboration with the Clinical research associate (CRA), Clinical trial assistant (CTA), Country Lead Monitor (CLM), Team leader (TL) and managerial Site management.

? For the quality enhancement, TQM/ TQSM works in close collaboration with Quality Strategy & Inspection Intelligence team (QSII), Study Audit Management team (SAM) and Quality & Compliance team.

? As system super user, Key work relations are globally system support team and locally with SM team.

? For functional training management, TQM/ TQSM / TQSM coordinates with other functions’ expertise for the appropriate training arrangement., development and performance review of direct reports in assigned client teams as needed.

 

 Requirements/qualifications：

? TQM, the incumbent must have a Undergraduate degree’ (or equivalent) with 5 years of relevant healthcare experience including 4 years monitoring & site management experience or 1 year full scope of clinical quality management experience or clinical project management or people management experience

? TQSM, the incumbent must have a Undergraduate degree’ (or equivalent) with 7 years of relevant healthcare experience including 4 years monitoring & site management experience or 3 year full scope of clinical quality management experience or clinical project management or people management experience

? Audit and inspection support experience are plus

? COMPETENCIES:
Core competencies: Issue resolution, Drive Results, Manage Complexity, Plan &Align
Leadership Competencies: Cultivates Innovation, Business Insight, Courage
Functional Competencies:
- Effective written and verbal English communication skills
- Customer Focus
- Awareness & understanding of cultural and regional operational differences
- Oral presentation & interpersonal skills
- Decision making
- Planning and organization, time management, prioritization
- Travel to sites, training and meetings, local and international level up to 50%

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