Company: IQVIA

Location: Reading

Job Description:

Responsible for ensuring delivery of high quality and timely TMF Quality Review activities for a portfolio of studies.

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.

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

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Posted: May 30th, 2026