Clinical Operation Quality Lead
Clinical Operation Quality Lead
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Job Description
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%
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Employment Type
Full-Time
