Connection profile

Rekha

About: Have around 16 plus years of work experience which includes 6 years of experience working in departments of biochemistry and molecular biology at the prestigious Indian Institute of Science, where I had worked as a project assistant and gained expertise in Deoxyribonucleic acid extraction, polymerase chain reaction, Deoxyribonucleic acid sequencing and gene scan. During my tenure I had assisted several research scholars and had been a part of various genomics projects. I moved on to take up data management role at Accenture in the year 2003. Was a part of transition and offshoring of CDM capability. Underwent training at the client site by onshore trainers. Went on to take up Subject matter expert and Team lead role. Further in my career I got the opportunity to take on training. Served as therapeutic area lead where led a team of 45 plus data managers, Team leads and Subject matter experts. Job role involved project management and liaison between the client and data managers, having the overall responsibility of managing all the studies in the therapeutic area including resource planning and had the responsibility of ensuring that all studies met their interim and lock timelines. Was instrumental in formulation of study specific editing guidelines where the standard editing guideline did not cover specific scenarios. I also had the opportunity to work with study build team in designing new Case Report forms or modifying the existing ones to suit the study. Worked with programmers to incorporate valdations to perform automated checks which reduced the number of manual checks in the studies. Conducted testing of validations for several studies. Suggested modifications to validations which were misfiring. Worked as clinical data project lead wherein I was an active member of the global study management team right from the study initiation to lock. In this role I had the opportunity to interact Project leads, medical monitors, clinical scientists, site monitors, statisticians etc. from the client end. After 8 years in data management I was entrusted the role of Pharmacovigilance drug safety unit team lead where I was responsible for managing a team of drug safety associates and project manage the same. In this job role I was a liaison between the client and case processors. Was responsible for case assignment and had to ensure that the entry timelines were met for the received documents on a daily basis. Tracking timelines was critical as delayed entry could impact the follow up timelines or submission to regulatory authorities. After serving the Pharmacovigilance industry for 2 years, I had to take a break from my career to take care of my daughter.