Document Management Oversight Lead

3 days ago


London, Greater London, United Kingdom Healthcare Businesswomen's Association Full time

Are you a motivated and experienced professional looking for a new challenge? Do you have a passion for clinical document governance and a proven track record of delivering high-quality results? If so, we may have the perfect opportunity for you

About the Role

We are seeking a Document Management Oversight Lead to join our team at the Healthcare Businesswomen's Association. In this role, you will be responsible for ensuring the delivery and oversight of high-quality and timely TMF Quality Review activities for a portfolio of internal, outsourced or BD&L studies.

Key Responsibilities
  • Drive the implementation of Clinical Document Governance Management initiatives, projects, and process improvement activities to enhance clinical document management systems, processes, and standards.
  • Develop and maintain subject matter expertise on TMF training materials, formal, and informal processes, and tracking tools for TMF oversight activities.
  • Collaborate with the CDM Process team and other key stakeholders to identify and communicate TMF risks/trends/patterns and implement pragmatic remediations.
  • Contribute to the development of audit/inspection readiness plans and support the execution of TMF quality reviews in preparation for audits/inspections.

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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