**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.
+ Support the foreca...