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 forecasting and tracking of TMF Quality Review resource needs including proactive identification of resources to support TMF Quality Review activities for high-risk and priority projects. Qualifications: Bachelor’s degree in life science/healthcare is required; or equivalent and relevant industry experience Minimum of 8 years working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organisations) with specific experience in clinical documentation and/or records & information management. Strong influencing and presentation skills. Ability to communicate effectively at all levels. High organisational awareness, including experience working in multi-disciplinary teams, across cultures and geographies. Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders. Fluent written and oral English This role is not eligible for UK visa sponsorship 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 https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.