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Mahendra _CDM 2 Years Experience

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Mahendra _CDM 2 Years Experience

  1. 1. COVERING LETTER Respected Sir/Madam, I am pleased to offer myself for a suitable position in your esteemed organization. I have pleasure in submitting my application for your kind perusal and favorable consideration. I am enclosing my resume and hope that I will get favourable reply from your side. I ensure you that I will give you a full satisfaction by extreme hard-work, complete dedication and sincerity in your esteemed organisation, if you will give me a chance to work with you. Thanking you in anticipation of a favourable reply. Yours Sincerely, (Mahendra reddy Challa)
  2. 2. Mr. Mahendra Reddy Challa Masters in pharmacy (Pharmacology) H.No:149, C.T. Street, Maratahalli, Bangalore -560037, INDIA (e): (c): +91-8884921188 Objective: To work in an organization with globally competitive environment on challenging assignments that keeps in touch with latest technology. To take an active participation for the development of organization, where there is also an ample scope of individual growth. Professional experience: • Currently working as Associate Clinical Data Coordinator-II at “QUINTILES INDIA PRIVATE LIMITED, Bangalore. Job Responsibilities: • Project Based Tasks. Data Management Plan: To understand the DMP and follow the guidelines contained within it. • Protocol: Basic understanding of the key aspects of the protocol. • Data Processing/Cleaning Tasks: To perform, under supervision, aspects of data review including – Review • Discrepancies and take appropriate action − Generate relevant queries and send for resolution by investigator site • Apply query resolutions to clinical database − Conduct quality control of CRF vs. database • Communicate issues Identified during data review to the DOC/Data team lead. • Project Meetings: Attend internal project meetings and ensure assigned actions are completed within the required Timeframe. • Non Project Tasks. Complete SOPs, WPGs and other role related training within the required timeframe. • Enter Timesheet information in a timely manner. Educational Background: COURSE YEAR COLLEGE/UNIVERSITY NAME PERCENTAGE SSC 2003-2004 St. PETER’S HIGH SCHOOL 86.0% Intermediate 2004-2006 RATNAM JUNIOR COLLEGE 91.8% B. Pharmacy 2007-2011 JNTUA UNIVERSITY 69.0% M. Pharmacy 2011-2013 JNTUA UNIVERSITY 78.0% DATA MANAGEMENT EXPERINCE Total Experience: Around 2.0 years exp in Clinical Data Management Trainee Clinical Data Analyst
  3. 3. November 2014 to Aug 2015 Associate Clinical Data Coordinator-I Aug 2015 to Feb 2016 Associate Clinical Data Coordinator-II Feb 2016 to till date. Data Management Activities performed Study Start Up • Test case writing. • Test data entry and validation. • Missing data checks writing and missing data report validation. • Listing validation. • UAT testing Study Conduct • Performing Query management & Listings review. • Perform Monthly Listings. • Meet the project objectives within timeline. • Performing the Vendor reconciliation, IVRS reconciliation. • Handling the RECIST data. • Performing Monthly dataset review activity. • Preparing subject status report/Subject data tracker for sponsor review. • Performing data transfers to sponsor as per timelines. • Proficient in coordinating with team members for any study related issues or potential risk in future. • Performing BIOS data review. Study Close out • All the subjects are clean through data Management quality plan & SOP’s Therapeutic Experience: Therapeutic Categories Specialized Area(s) Phase(s) Role(s)/Year(s) of Experience Oncology Diabetes Prostate Cancer Phase-II Clinical Data Review: 1.10months Technical Skills: • InFrom5.5 (Trained and Experienced) • Rave (Trained). • Good Knowledge on RECIST • Sound knowledge of all relevant regulations, including GCP.
  4. 4. • Excellent computer skills including but not limited to Data Management system, Ms Office products. • Relevant interpersonal, verbal and written communication skills. Awards: • Received Thank you Award for maintaining quality and dedication. • Received award for contribution on study and performance. Declaration: I consider myself familiar to pharmaceutical and pharmacological aspect and guidelines and I’m confident about my ability to work with/ within a team and I hereby declare that the above furnished information is correct and true as per my knowledge. Place: Bangalore Yours Faithfully Date: Mahendra Reddy.CH