Katerina Ilieva

• Clinical Trial Management: Oversee the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and timelines.
• Resource Allocation: Ensure appropriate allocation of staff, equipment, and resources to meet clinical needs.
• Quality Assurance: Maintain high-quality standards and compliance with Good Clinical Practice (GCP) and other regulatory requirements.
• Leadership: Lead, mentor, and manage clinical operations teams, including, coordinators, and clinical research staff.
• Recruitment and Training: Oversee recruitment, training, and professional development of clinical staff.
• Performance Evaluation: Monitor and evaluate staff performance to ensure alignment with organizational goals.
• Regulatory Adherence: Ensure compliance with local, national, and international regulations governing clinical trials and healthcare operations.
• Audit and Inspection Preparation: Prepare for and manage audits, inspections, and reviews by regulatory bodies or sponsors.
• Stakeholder Engagement: Serve as the primary liaison between clinical operations and other departments, sponsors, vendors, and regulatory authorities.
• Conflict Resolution: Address and resolve operational challenges and conflicts effectively.
• Reporting: Provide regular updates and reports to senior management on the status of clinical operations and trials.
• Metrics and KPIs: Develop and track key performance indicators (KPIs) to assess the effectiveness and efficiency of clinical operations.
• Process Improvement: Identify areas for improvement and implement strategies to enhance operational efficiency.
• System Implementation: Oversee the adoption and integration of clinical management systems and tools.
• Innovation: Stay updated with industry trends and implement innovative practices to improve clinical operations.

• Company Overview: Providing services for Johnson and Johnson Bulgaria
• Study Management and Oversight

Manage and oversee clinical trials at the country level to ensure adherence to regulatory and company standards.
Coordinate all aspects of trial activities, including planning, initiation, execution, and close-out phases.

• Regulatory and Compliance Activities

Facilitate the submission of regulatory documents to the local health authority.
Ensure compliance with applicable regulations, guidelines, and standard operating procedures (SOPs).

• Central Review and Findings

Manage central review processes to identify and address findings promptly.
Conduct root cause analysis for identified issues and implement corrective actions.

• Review and Approval Processes

Review and approve informed consent forms (ICFs) for consistency with protocol and regulatory requirements.
Oversee the review and approval of trial reports and related documentation.

• Site Selection and Activation

Coordinate the selection of trial sites based on feasibility assessments and strategic considerations.
Ensure timely site activation and readiness for study initiation.

• Communication and Coordination

Serve as the primary point of contact between the local team, global study team, and external stakeholders.
Ensure timely communication of study progress, risks, and mitigation plans.

• Monitoring and Quality Control

Monitor the performance of sites to ensure compliance with protocols and quality standards.
Address any deviations, delays, or quality concerns at the site level.

• Line Management and Team Support

Provide partial line management or mentoring support to team members as needed.
Foster a collaborative environment to promote team efficiency and alignment with study goals.

Writing Standard Operating Procedures (SOPs) as a mix of technical, organizational, and communication needs to ensure the document is clear, concise, and actionable

Conducted training sessions for teams on identifying and addressing business needs. - Trained over 20 team members across departments, fostering better collaboration and goal alignment. Developed customized learning materials and workshops to educate stakeholders on strategic goals.

Facilitated discussions and brainstorming sessions to align team activities with business objectives.

Delivered presentations on business requirements and their importance in achieving organizational success.

• Risk Management

Identify, document, and manage risks throughout the trial lifecycle. Implement and track mitigation strategies to ensure smooth study operations.

• Documentation and Reporting

Maintain accurate trial documentation, including study-specific files and reports. Review and ensure quality of site-specific and study-level documents.

• Responsible for reviewing and approving the monitoring reports, LCRA for studies with therapeutic indications - Dermatology - Atopic Dermatitis and Rheumatology -Rheumatology arthritis
• Site Management Responsibilities, Responsible for Root Cause Analysis, Regulatory Submission, and ICFs reviewing procedures

• Monitoring Essentials & the Trusted Process
• Clinical Foundations Curriculum
• Foundations (GCP) Training
• Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures
• Primary responsibility is for site management and performance, including documentation
• Site management activities include all in-house and on-site monitoring for all visit types

• Support Site ID specialist and patient recruitment planning process to deliver high-quality data
• Defined optimal site profile for a study and recommend the best, high-quality sites for studies after contacting and evaluating their capabilities and potential for study conduct
• Accountable for the timely tracking of essential documents and ensured completeness of the trial master file (TMF) for assigned clinical studies, according to appropriate regulations and guidelines
• Assisted CRAs with preparation, handling, and distribution, filing, and archiving of clinical documentation
• Administrative support and corresponding with study site teams
• Assist at site visits if required
• Coordinated and follow-up site payments
• Organized and reviewed translations of study documents

• Maintained communication and correspondence with subjects, sponsor, monitor, and other study personnel
• Participation in the subject recruitment process
• The prepared site for study initiation
• Provided technical support in AE, SAE, SUSARs documentation
• Performed study/protocol procedures in a detailed, accurate manner
• Provided training to subjects in clinical trials
• Supported PI/SI's to complete case report forms
• Adhere to good laboratory practices in samples processed and collected and shipment preparation

• Ensuring that different treatments are compatible
• Checking dosage and ensuring that medicines are correctly and safely supplied and labeled
• Received and verified the prescriptions
• Priced and filling of prescriptions
• Obtained pharmacist's approval
• Advised patients of any adverse side-effects of medicines or potential interactions with other medication/treatments
• Managed inventory, included monitoring, re-stocking, expired products, and inventory management
• Maintained computerized lists of medications taken by patients related to the National Healthcare Fund