Physician with 16 years of experience in clinical research and patient care. 2 years of postgraduate training in internal medicine. Expertise in providing medical direction into various phases of clinical development, study design and clinical data analysis, managing research teams and projects, monitoring and reporting of serious adverse events (SAEs), and monitoring of investigative sites. Work in drug development has encompassed several therapeutic areas with special emphasis on anti-infectives, oncology, hematology/blood products, neurology, CNS, gastroenterology, women's health, endocrinology, and cardiology. Strong knowledge of Good Clinical Practices, FDA regulations, ICH, and HIPPA guidelines. Team player with well developed leadership, and an ambitious professional with excellent oral, written and interpersonal skills. Ability to plan and establish priorities, flexibility and ability to adapt to changing conditions in a fast paced environment, detail oriented, and time management skills.
I am a clinical research professional with global experience in all phases of clinical trials from study start-up through close out. I also have experience in clinical trials management, including CRO and Vendor management, audit preparation, personnel and GCP training, investigator meeting presentation, contract negotiation and execution, and database, eCRF, and protocol development.