Sameer Khan

Pune, India
Data Manager
Sameer Khan

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.

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

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Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

Mother-to-Child Transmission (MTCT) of HIV: India SWEN Study

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Primary and secondary analyses of the India SWEN study, an NIH-funded phase III randomized controlled trial of an extended nevirapine prophylaxis regimen among 783 HIV-infected pregnant women and their breastfed infants in Pune, India.

Extended-dose nevirapine to 6 weeks of age for infants to prevent HIV transmission via breastfeeding in Ethiopia, India, and Uganda: an analysis of three randomized controlled trials

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The Lancet
Background: UNICEF/WHO recommends that infants born to HIV-infected mothers who do not have access to acceptable, feasible, affordable, sustainable, and safe replacement feeding should be exclusively breastfed for at least 6 months. The aim of three trials in Ethiopia, India, and Uganda was to...