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[QUOTE=Guest-IJT;113259][b]Name [/b]: k.sreenivas [b]Email [/b]: sreenivaskanna86 AT gmail.com [b]Designation / Skillset[/b] : clinical reaserch co ordinator I completed M.Sc Biotechnology , with Clinical data management, Clinical trials, and SAS programing [u][b]Resume[/b][/u] : CAREER OBJECTIVE Seeking a challenging & rewarding opportunity with an organization of repute which recognizes and utilizes my true potential while nurturing my analytical and technical skills in the field of Clinical Research/ Clinical Data Management/ SAS Programming. SKILLS - Able to work under optimal supervision - Excellent organization, planning and problem solving abilities. - Excellent negotiation and analytical skills. - Established interpersonal and communication skills. - Able to work effectively and efficiently in a matrix environment. - Ensuring the implementation of project plans as assigned. [b]SUMMARY [/b]: - Extensive knowledge on various SAS Products like SAS/Base,SAS/Access,SAS/SQL,SAS/Macros ,SAS/STAT SAS/Graphs and SAS/ODS. - Having better knowledge in following areas in SAS. - Data reading and validation - Data sub setting and summarizing as per the reporting needs - Data analysis by using various SAS Procedures - Used Output delivery system extensively to generate reports in HTML, RTF, PDF and EXCEL reports EDUCATIONAL QUALIFICATION - Certificate course on “Clinical Research” Aravinda Biosolutions Pvt.,Ltd.Hyderabad - M.Sc. (Biotechnology) from MARUDUPANDIYAR College Thanjavur (Bharathidasan University) Tamilnadu With 68.5% in the year 2009. - B.Sc in Microbiology (2004-2007) in Vivekananda Degree college affliated to Kakatiya University Warangal with 51.5% aggregate. [b]Has the good understanding on the following [/b]: [b]CLINICAL DATA MANAGEMENT [/b]: - EDC work flow process. - Study Build. - CRF Development Specifications. - CRF Designing. - Data Validation Plan Specifications. - CRF annotation. - SDTM mapping specifications. - SAE Reconciliation. - External Data Reconciliation. [b]CLINICAL TRAIL MANAGEEMENT [/b]: - ICH GCP Guidelines - 21 CFR Part 11 - Interpretation of Protocol [b]- Trial Design Concepts [/b]: - ARM - Randomization - Blinding Parallel/Crossover Studies - Interpretation of Time of Event Schedule - Essential Documents (Trial Master Files) - E2A Guidelines - Site feasibility, Site Initiation, Interim monitoring, Site Close out visits. [b]EXPERIENCE [/b]: - SIX months experience at “ARAVINDA BIO SOLUTIONS pvt.ltd” as a “SAS trainee programmer”. SUBJECTED STUDIED 1 Tissue culture. 2 Immunology and Immuno Technology. 3 Bioprocess Technology. 4 Recombinant DNA Technology. 5 Microbial Biotechnology. PROJECT PROFILE TITLE - Isolation And Identification Of Pathogenic Bacteria From “Burnwound Sample” [b]Project Description [/b]: As a clinical programmer mostly involved in the analysis of clinical trials.. This particular project is for testing a new molecule. The data is provided in the form of excel sheets. The data has been imported from the excel sheets to the SAS system. The data management steps have been applied using different Base SAS procedures in compliance with the protocols provided. Data has been analyzed using different statistical techniques. The result has been delivered to the client in form of graphs, reports and summaries. [b]Responsibilities [/b]: - Created Reports using Base SAS Reporting Procedures. - Involved in delivering output using ODS (output deliverSystem)and also created Listing ,summary Reports. - Created SAS data Sets. Created macros to generate safety reports [b]DESCRIPTION [/b]: The raw data which is stored in Excel sheets and This data was transferred to SAS System using SAS/ACCESS and data sets were created. All statistical reports were generated in the SAS system using Base SAS and SAS/STAT procedures. [b]DECLARATION [/b]: I hereby declare that the above mentioned information is correct up to my knowledge andI bear the responsibility for the correctness of the above mentioned particulars. [b]PLACE [/b]: HYDERABAD (K.SREENIVAS) ------------------------------------------------------- [b]More Information about this submission and submitter [/b]:- ___________________________________________________ [b]Submission ID [/b]: 4217054 [b]Date & Time [/b]: 6th Jun 2011 11:14 AM (UTC) [b]IP Address [/b]: 121.243.133.102 [b]Browser Info [/b]: Mozilla/5.0 (Windows; U; Windows NT 5.1; en-US; rv:1.9.2.13) Gecko/20101203 Firefox/3.6.13 Predicted Country []: India[/QUOTE]
