Clinical Study Quality Assurance Specialist

2 weeks ago


Shanghai, Shanghai, China IQVIA Full time

Clinical Study Quality Assurance Specialist

We are seeking a highly skilled Clinical Study Quality Assurance Specialist to join our team at IQVIA. As a key member of our clinical research team, you will be responsible for ensuring good clinical practices and regulatory requirements are met for assigned clinical studies.

Key Responsibilities:

  • Work with Clinical Research project managers to identify and resolve non-compliance issues within lines of business
  • Ensure timely CAPA implementation by following up with CAPA owners and scheduling meetings as necessary
  • Participate in project meetings and provide timely assistance for all quality-related topics
  • Participate in Vendor's Quality Assurance Meetings and ensure quality oversight
  • Contribute to the selection of Service Providers and ensure quality oversight
  • Support the management of Quality issues/ deviations in collaboration with Service Providers
  • Implement quality agreements with Service Providers
  • Deviation and major breach management
    • Ensure documentation, investigation, and tracking of major deviations and potential Serious Breaches in GCP
    • Organize and coordinate deviation assessment meetings, providing meeting minutes and ensuring communication and escalation as appropriate

Audits and Inspections

Support the audit activities: provide information to audit groups for their risk assessment and audit activities, facilitate further investigation of observations (when needed), root cause analysis, and definition of CAPA. Assist in the preparation and conduct of inspections as required.

Training

Support the training sessions with SMEs, by reviewing training materials or participating in presentations where needed. Liaise with process owners and trainers to ensure appropriate training material is generated and made available for clinical research activities.



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