Position Overview
Job Overview:
Responsible for ensuring delivery of high quality and timely TMF Quality Review activities for a portfolio of studies.
Essential functions:
Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies.Ensure TMF Quality Review activities are conducted as per process, in adherence with quality standards and defined timelines.Identify and communicate TMF risks/trends/patterns and work with key stakeholders to define and implement pragmatic remediations. Monitor service metrics and act as point of escalation for issues.Support TMF oversight team in identifying opportunities for improvement to the operating model, training materials and tracking tools.Provide Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contributes to root cause analysis identification and creation/delivery of CAPAs....