Nenad Djurkovic

• Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, conduct of pre-study and initiation visits • Ensuring the integrity of the data submitted on Case Report Forms (CRFs) • Preparing ICFs to be in compliance with GCP and country regulatory requirements • Assisting with the administration of clinical research projects, recruiting investigators and site management • Tracking and following-up on serious adverse events

• Working exclusively for Sponsor’s company – Merck, Sharp & Dohme • Planning and coordinating activities for Study Start Up within the country • Providing recommendations and guidelines to global study management on local regulatory requirements • Performing country/site budget development and Contract negotiations • Performing CRF review, query generation and resolution • Assisting Senior CRAs with on-site tasks • Initiate, monitor and close out clinical investigative sites under direct supervision

• Assisting Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines. • Experience in following study indications: - Rheumatoid Arthritis (phase II and III) - Multiple Sclerosis (phase II and III) - Malignant Melanoma (phase I, III and IV) - Schizophrenia (phase III) - Malignant Tumor of Breast (phase III)

• Initial and trial ongoing documents preparations and submissions to local Ethics Committees and Regulatory Authority • Assisting CRAs during Site Monitoring Visits • Preforming various trainings in Quintiles working procedures and systems (eSOPs, CTMS, Infosario)