Tijana Vukojicic

Leading the planning and delivery of Clinical Trials Protocols and Result Summaries disclosure. Supervising the development and quality of output. Streamlining the overall project from beginning to the end. Workload and budget planning, reviewing and approving invoices, ensuring full compliance with operating procedures, quality standards and applicable regulations. Simultaneously overseeing multiple deadlines, training and coaching the junior members of the team.

Proactively driving Clinical Trials from start-up activities through database lock and close-out activities. Coordinating the Trial team activities in accordance with GCP, SOPs and other regulatory requirements. Developing clinical trials Protocols, implementing and updating policies, SOPs and Work Instructions. Planning the budget, reviewing and approving invoices. Acting as a Lead CRA on multiple studies, providing training and guidance to country CRAs.

Responsible for the site selection, study start-up document review and tracking, regulatory authority submissions, recruitment follow-up, site status tracking, IMP accountability verification, CRF review and query resolution. Providing accurate, timely, and consistent study information to both sponsors and internal departments to support the business needs of Kendle. Maintaining relationships with study sites and patients from study start-up to study close-out.

Follow-up and monitoring of study activities through tracking and review of study progress. Ensuring high performance of the clinical team and reporting progress to the sponsor. Identifying and resolving all the issues with sites and investigators according to the Radiotherapy Quality Assurance guidelines and the study Protocol. Preparing SOPs, ISO documents, presentations and required reports, data management.

Master of Arts in International Politics