Anja Leuschner

Background

About Anja Leuschner

As a highly motivated professional with over 20 years in the pharmaceutical industry, specialized in clinical documentation & information management, I am dedicated to ensure highest standards of quality, compliance, and efficiency in clinical trial documentation processes. My expertise spans various aspects of clinical documentation & information management, contributing significantly to the success of clinical trials. Document & Data Management:* Independently manage and maintain high-quality records, coordinating with cross-functional teams and streamlining document lifecycle operations to enhance efficiency and compliance * Consistently contribute to the successful start-up, maintenance, and close-out of numerous clinical trials * Experienced user of Veeva Vault Clinical applications (incl. eTMF and CTMS)* Support data visualization, analysis, and optimization efforts to enhance information management and drive continuous innovation and process improvement initiatives * As the designated archivist for all vaccine studies, manage both paper and electronic records, ensuring efficient archival, retrieval, and access based on business needs Quality Control and Compliance:* Conduct ongoing quality control of eTMF activities to ensure inspection readiness and compliance with regulatory requirements from study start-up to archiving * Monitor eTMF quality issues and collaborate with relevant stakeholders (sponsors/vendors) to resolve them effectively * Escalate limiting factors and non-compliance issues to appropriate functions, providing comprehensive guidance on resolution strategies Guidance and Support:* Collaborate closely with Clinical Trial Managers and Program Managers to create and maintain trial-specific documents and databases * Provide comprehensive support to cross-functional team members on eTMF processes and related requirements according to SOPs and guidelines * Contribute to the revision of eTMF processes and system enhancements, offering business support for necessary improvements Audit and Inspection Support:* Review study TMF management plans and offer relevant input to ensure robust clinical documentation processes * Provide support during audits or inspections, leveraging my expertise to address any documentation challenges Leadership and Mentorship:* Mentor and onboard new team members and junior resources, fostering a collaborative environment and ensuring seamless integration within the team * Supervise activities and maintain relevant tools, coordinating team meetings to promote knowledge sharing and best practices