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1. Page 1 of 3 M.VENUGOPAL Present Address: Mobile no: +917824032111 Flat No 303, Ashritha Apartments E-mail: Venu_data@yahoo.com Perungudy, Chennai 600096…
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  • 1. Page 1 of 3 M.VENUGOPAL Present Address: Mobile no: +917824032111 Flat No 303, Ashritha Apartments E-mail: Venu_data@yahoo.com Perungudy, Chennai 600096 ------------------------------------------------------------------------------------------------------------------------------- CAREER OBJECTIVE Seeking a responsible position in the Clinical Research Organization that will purposefully utilize my experience while offering several opportunities for my professional enrichment. SUMMARY  4 years’ experience in the field of Clinical research Operation and Clinical Data Management.  Working as Clinical data coordinator ICON Clinical research India (P) LTD (23Feb 2015 till date )(Therapeutic areas include Oncology & Musculoskeletal )  Working as a Clinical research Core Monitoring at (CRO) Klinera Corporation India (Aug 2014 to 20 Feb 2015).  Worked as a Clinical research Coordinator at Global Clinical Research Services Pvt. Ltd (Aug 2013 to Aug 2014). EDUCATIONAL QUALIFICATIONS  ADVANCED POST GRADUATE DIPLOMA IN CLINICAL RESEARCH AND MANAGEMENT FROM CREMA affiliated to JAIPUR NATIONAL UNIVERSITY 2011.  B.Sc. MLT (Medical lab Technician) Graduated from SHARVAANIINSTITUTE OF PARAMEDICAL SCIENCES, Warangal affiliated to DR. NTR University of health sciences in 2010. CLINICAL DATA MANAGEMENT SKILLS • Query management • Manual review and checks • IVRS reconciliation • SAE Reconciliation (SAE) • Database locks (Freezing and Locking). • Database user acceptance testing • Edit check user acceptance testing
  • 2. Page 2 of 3 Clinical Data Coordinator • Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures. • Accurately and consistently apply data handling and Case Report Forms as necessary in accordance with all applicable procedures. Perform Quality Reviews and appropriately address all issues. • Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings. • Independently and accurately generate data queries to resolve data discrepancies. Appropriately address responses to data queries and accurately update the clinical data as necessary. • Identify and accurately resolve all workflow or clinical data discrepant issues. Independently and accurately prepare database test documentation and test data entry screens. Assist with the validation of edit check programs. • Assist with the development, review and the update of relevant Data Management Study Specific Procedures. Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures. • Accurately perform external data reconciliation in accordance with all applicable procedures. Generate, review for accuracy and distribute status reports as requested. Assume study lead role when applicable. • Represent Data Management at internal / external meetings as appropriate. Effectively mentor less experienced staff. This may include assisting and guiding new personnel during their initial training period. • Understand and comply with core operating procedures and working instructions. • Develop and maintain good communications and working relationships with CDM team. • Resolve data clarification APPLICATION & TECHINICAL SKILLS  Gained experience into Clinical Data Management tools like Oracle Clinical 4.6, Inform 4.6 and Medidata5.6.  Diploma in a computer’s hardware and trouble shooting.  Good knowledge in Microsoft products such as:MS- Word, Excel, & Power Point.  Good knowledge in web browsing and WindowsXP, Windows 7 and Windows 8 &10.
  • 3. Page 3 of 3 IN CLINICAL OPERATIONS  Worked with various therapeutic areas like Pulmonology, Neurology, Nephrology, Diabetic and Hepatology (On-going) in Phase III and IV. S.No Phase, Indication of the trial SPONSOR (International / National) No of Studies 1 Phase III Asthma International 01 2 Phase III COPD International 02 3 Phase IV Neurology International 01 4 Phase IV Hepatology(Ongoing) International 03 ACHIEVEMENTS  Inspire (Take a Bow) Award’s in 2016 for process improvement and providing the deliverables well before timelines.  Received several appreciations from on shore team (CDL)team leads, line manager.  Nominated as a Global Clinical Research Services (GCRS) ‘Employee of the Year’ award for the 2014 and 2015. TRAINING AND CERTIFICATION  Attended the Investigator meeting(DELHI) Received the trainings (ICH-GCP, eCRF, AE, SAE Reporting).  Oracle RDC, Inform and Rave Medidate eCRF online training Certification as a Clinical research Coordinator from Sponsor and CROs and data management teams. PERSONAL DETAILS  NAME :VENUGOPAL.M  Fathers Name :VENKATACHARY.M  Mother Name :ARUNA  Date of birth :05-11-1986  Languages Known :English, Hindi and Telugu DECLARATION I hereby declare that the information furnished above is true to the best of my knowledge.
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