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Sameer Khan is Data Manager for the BJ Medical College Clinical Research Site (BJGMC-CRS) in Pune, India for clinical studies funded by two NIH trial networks: the AIDS Clinical Trial Group (ACTG) and the International Maternal Paediatric Adolescent AIDS Clinical Trials (IMPAACT). He has 12 years of experience in clinical data management, and has been working in computer science projects for the last 20 years.
He worked as Database Administrator cum QA/QC administrator on a collaborative, NIH-funded clinical trial conducted by Johns Hopkins University, Baltimore, USA and BJ Medical College titled “Prevention of Maternal to Infant HIV Transmission in India: A Randomized Clinical Trial ‐ A Single Dose of Nevirapine (NVP) to Mothers and a Single Dose to Infants Compared to Additional NVP to Breast‐fed Infants Until 6 Weeks Postpartum (SWEN Study).
Mr. Khan is trained in HSP-GCP and HIPPA guidelines. He is responsible for all data management activities at the site, including QA/QC of CRFs/source documents, supervising QA/QC officers and QC activities. Supervise data entry of CRFs, submit data to FSTRF DMC, coordinate with clinicians and other staff for completion of CRFs and resolve queries generated during QC process and those received from FSTRF DMC. He is responsible for maintaining a good score in the monthly ACTG/IMPAACT data management site reports, and implementing new strategies to improve DM performance.
He coordinates with study staff to develop protocol source documents and checklists, supervises data management staff, conducts training for staff, writes data management standard operating procedures, monitors protocol related activities related to data management, maintains logs for screening & enrollment and follow-up visits, and calculates retention for enrolled participants.
Mr. Khan also attended ACTG/IMPAACT trainings and meetings at Washington DC.