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RESUME_Arjun Kulshrestha
- 1. RESUME Mr. Arjun Kulshrestha Mobile - +91 9108698576 Residence - +91 8828227575 E-mail id - arjunkul.pro@gmail.com Personal Profile I am young enthusiastic pharmacist craving to build my career in the field of Clinical Research. To keep building my knowledge and enhance my working ability and be a valuable asset to organization. Being a Clinical Researcher Im planning to get various international certifications related with Clinical Research. Professional Experience Quintiles 10Aug2015- Till date. Role: Clinical Data Coordinator Responsibilities: Practical hands on: RAVE Have worked on Study Startup, Conduct and close out activities in Clinical data management on RAVE EDC trials Worked as a study Data Operations Coordinator (DOC) for multiple studies. Written Edit checks in DVS and involved in validation of Edit Checks. Prepared eCRF Completion Guidelines. Written UAT test scripts for both front end and backend Checks. Also prepared UAT Plan & UAT report Performed UAT testing in HPALM environment. Involded in review of eCRFs and Annotated eCRFs Performed Migration for one of my studies. Performed SDTM dataset validation for regular data transfer. Also performed dataset transfer for study milestones Review WEBSDM Checks which help in ensuring that datasets generated are per Specifications. Closely worked with programmers to fix the structure issues in dataset. Perform usual data cleaning activities and as a DOC mentor the new team members on same. Share the study Metrics report with the Client on an ongoing basis. Also handle the study calls with Client.
- 2. Perform SAE Reconciliation and also involved in SAE reconciliation calls with clinical team. Worked on external data reconciliation. Also performed validation of Vendor test transfer in order to ensure that the transfer file is per the agreed tsDTA. Worked on locking activity after the completion of data cleaning. Also worked on tracking the investigator signatures in casebooks, which is a part of close out activities. Cognizant Technology Solutions Pvt. Ltd. 8th OCT2013 14Jul2015. Role: Junior Data Analyst Responsibilities: Practical hands on: Oracle Clinical v4.6, INFORM v6.0 Preparation of Edit Check Specifications. Performing Quality Control activities during the course of Data trial in order to minimize the inconsistencies and inaccuracy of data. Performing Edit Checks Verification after Execution. Generate data queries based on Validation checks or Errors and Omissions identified during data entry, Improving Inconsistencies and Inefficiencies in processes, Recommending solutions. Perform early and final database QC activities. Perform External data Reconciliations (LAB) and Reconciliation of SAEs. Review the resolved Discrepancies and close where appropriate to ensure an Error free, quality Data with no open queries. Attend relevant study Teleconference with the Study team and give Feedbacks as required on the Data. Review and Resolve data Discrepancies identified by the system or through Manual checks as Identified in the Data editing Guidelines. Actively review and provide feedback on study productivity Tech Observer India Pvt. Ltd. 20th MAY 2013 29SEP 2014. Role: Clinical Data Associate Responsibilities: Practical hands on: Oracle Clinical v4.6 Conduct sponsor User Acceptance Testing (UAT) of EDC & Paper based CDMS systems to assure screen design matches protocol. Preparation of Edit Check Specifications. Query Management based on Validations Checks or Errors. Proficient in Oracle Clinical Data
- 3. Performing Quality Control activities during the course of Data trial in order to minimize the inconsistencies and inaccuracy of data. Performing Edit Checks Verification after Execution. Generate data queries based on Validation checks or Errors and Omissions identified during data entry, Improving Inconsistencies and Inefficiencies in processes, Recommending solutions. Perform early and final database QC activities. Perform all External data Reconciliations(LAB, etc) and Reconciliation SAE Review the resolved Discrepancies and close where appropriate to ensure an Error free, quality Data with no open queries. Creation of Data Entry Guidelines ,Self Evident Correction Convention(SECC) and Maintenance of DMTMF Documents. Attend relevant study Teleconference with the Study team and give Feedbacks as required on the Data Skills: Excellent computer skills including; not limited to knowledge of Clinical Trial/Data Management Systems; MS Office products etc. Sound knowledge of all relevant Regulations, including GCP Proficiency with Statistical Analysis Packages (SAS). Excellent Interpersonal, Verbal and written Communication skills Ability to identify and solve complex problems by using a Logical, Systematic, Sequential approach. Education CDM, Clinical Operation, Pharmacovigilance & SAS, 2013. PG Diploma in Clinical Research Clinovision Institute New Delhi (Delhi). Bachelor of Pharmacy, 2012 with Avg. 72% Rajasthan University of Health Science - Jaipur, Rajasthan. Higher Secondary School Certification (HSC), 2008 with Avg. 61% Saraswati Vidhya Mandir Etah, Uttar Pradesh.
- 4. Personal skills Comprehensive problem solving ability, good verbal & communication skills, ability deal with people diplomatically, willingness to learn, team facilitator, Smart worker. Interests: Discrepancy management, project development, troubleshooting, travelling and music. Achievements Received Triumph Award twice for achieving the Interim Database lock and achieving Go- Live for the study. Received STAR of the Month Award for achieving the key milestone for the study before the desired time. First prize for band performance at TAJ Mahotsav, Agra Secured 2nd position in intercollegiate Debate competition as captain. Personal details Date of birth : 02/NOV/1989 Gender : Male Marital status : Single Nationality : Indian Languages known : English and Hindi. Hobbies : Reading, Listening music, Drumming, Photography and Travelling. Permanent address : s/o K.K. Kulshrestha, D-26, Rangoli Colony near Sikandra, Agra (U.P). Declaration: The information furnished above is correct and true to the best of my knowledge Date: Place: Mr Arjun Kulshrestha.