Quality Specialist II, Clinical Programming
in conjunction with operational staff, develop and implement a quality framework (processes and associated training materials). Ensure that the framework is appropriately updated and effective. Provide advice and support to operational staff in functional and cross-functional process application and adherence. Drive the improvement of the quality framework as necessary. • Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and head of the eClinical Process &amp; Training as appropriate.• Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).• Provide support and advice to operational groups on the application of, and adherence to processes and the use of systems.• Support eClinical Process &amp; Training and operations staff at audits, client assessments or regulatory inspections, as needed.• Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues.• Facilitate reporting, handling and follow up of Quality Issues
Title: Quality Specialist II, Clinical Programming
Salary: None
Description: in conjunction with operational staff, develop and implement a quality framework (processes and associated training materials). Ensure that the framework is appropriately updated and effective. Provide advice and support to operational staff in functional and cross-functional process application and adherence. Drive the improvement of the quality framework as necessary. • Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and head of the eClinical Process &amp; Training as appropriate.• Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).• Provide support and advice to operational groups on the application of, and adherence to processes and the use of systems.• Support eClinical Process &amp; Training and operations staff at audits, client assessments or regulatory inspections, as needed.• Research and advise on relevant regulatory and industry trends and initiatives to ensure company stays current on GxP compliance issues.• Facilitate reporting, handling and follow up of Quality Issues
Requirements: None experience, None education
Fraudulent: Yes