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 I’m 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 eCRF’s and Annotated eCRF’s
 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.