Carmen Yordanova

• Oversaw the management and quality assurance of Trial Master Files (TMFs) across multiple clinical trials within the portfolio, ensuring compliance with GCP, ICH guidelines, and regulatory requirements.
• Developed and implemented TMF governance frameworks and quality management systems to ensure high standards of documentation and inspection readiness.
• Coordinated with project managers, clinical operations, and regulatory teams to ensure alignment and integration of TMF activities across all studies.
• Led cross-functional teams in conducting regular TMF audits and quality reviews, identifying discrepancies, and driving corrective actions to resolve issues.
• Provided strategic oversight and guidance on TMF processes, implementing best practices and continuous improvement initiatives.
• Delivered training and mentorship to TMF administrators and project teams, enhancing their knowledge and adherence to regulatory requirements and company standards.
• Utilized Wingspan eTMF system to manage TMF documents, track milestones, and ensure timely submission of essential documents.
• Analyzed TMF metrics and generated reports for senior management, supporting data-driven decision-making and process optimization.
  

Key Achievements:

• Successfully led the TMF management for a portfolio of over 30 clinical trials, contributing to increase of KPIs by 10%.
• Introduce to client new KPI reporting slide to increase visibility by creating automated KPI reporting tool.
• Streamlined processes across the portfolio by training dedicated QPMs by having regular 1:1 meetings.

• Led implementation and management of Trial Master File (TMF) processes, ensuring compliance with regulatory requirements and company standards.
• Developed and maintained TMF Quality Plans, identifying and mitigating risks to ensure document quality and inspection readiness.
• Collaborated with cross-functional teams including Clinical Operations, Regulatory Affairs, and Quality Assurance to support clinical trial activities and ensure TMF completeness.
• Conducted regular TMF reviews and audits, identifying gaps and implementing corrective actions to maintain high-quality documentation.
• Provided training and guidance to project teams on TMF best practices and regulatory requirements.

Key Achievements:

• Successfully managed TMF for multiple Phase III oncology clinical trials, contributing to timely delivery, increase KPIs and decrease in audit finings.
• Implemented a new TMF quality control process that reduced document errors by 30%.
• Led a cross-functional project team to transition from a paper-based TMF system to an electronic TMF (eTMF), improving efficiency and compliance.

• Conducted Quality Trial Master File Review per guidelines and principles.
• Identified and corrected document inaccuracies, creating and assigning Action Items.
• Completed document reviews and cross checks within timelines.
• Supported timely delivery and communicated findings to QPM.
• Acted as mentor for other TMF Specialists as needed.

• Supporting the upload of documents to the TMF structure and assuring the quality and integrity of the data
• Performing indexing activities and support for customer platforms
• Maintaining a structured and organized physical storage
• Preforming consolidations at the end of the study including preparing and sending the final pack of physical documents to the sponsor.