Clinical Document Governance Specialist
1 month ago
We are seeking a highly skilled Clinical Document Governance Specialist to join our team at the Healthcare Businesswomen's Association. This is a hybrid role that can be based in Dublin or London offices, with an expectation of being in the office 12 days/month.
Job DescriptionThe successful candidate will be responsible for ensuring delivery and oversight of high-quality and timely TMF Quality Review activities for a portfolio of internal, outsourced or BD&L studies. They will drive implementation of Clinical Document Governance Management initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards at the Healthcare Businesswomen's Association.
Responsibilities- Responsible for timely assessment of quality and completeness of TMFs for an assigned portfolio of studies.
- Identify and communicate TMF risks/trends/patterns and work with key stakeholders to define and implement pragmatic remediations.
- Serve as Subject Matter Expert on TMF training materials, formal, and informal processes, and tracking tools for TMF oversight activities in collaboration with CDM Process team and other key stakeholders.
- Provide Audit/Inspection readiness support by driving TMF quality reviews in preparation for audits/inspections, contribute to root cause analysis identification, and creation/delivery of CAPAs.
- Identify and implement improvements to document management processes to improve quality of TMFs. May act as business lead for innovation projects to enhance TMF quality assessment.
- 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.
- Support definition and refinement of TMF management strategy for assigned portfolio of studies.
Requirements
- Bachelor's degree or equivalent and relevant industry experience.
- Minimum of 5 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.
- Demonstrated success in planning and executing cross-functional projects.
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