Seema Jain

Background

About Seema Jain

Experienced clinical research professional with portfolio of success in clinical trial management and cross-functional relationships. Extensive knowledge of clinical research design, execution and facilitation of a clinical trial. Experience in Neuroscience, Cardiovascular, Oncology and Infectious Disease Research trials. Able to manage multiple studies simultaneously, from inception to completion. Skills: • Therapeutic areas INCLUDE Oncology, cardiology, neuroscience, and infectious disease. • Detailed knowledge of FDA regulations, GCP/ICH guidelines, and trial related regulatory requirements. • Proficient in Microsoft Office, Word, Excel, CTMS • Proficient in various Electronic Data Capture (EDC) systems such as Medidata RAVE, Oracle, Medrio, Endpoint,eClinicalOS, Inform. • Ability to coordinate and lead local teams to high performance and to lead across several dimensions simultaneously • Excellent communication and organization skills. • Effectively multi-tasks different complex assignments and responsibilities • Manage study start up activities (Feasibility, CDAs), regulatory functions, contract/Budget, and finances.