Ashok Kota is seeking a position in data management and regulatory writing. He has over 1 year of experience in data management, preparing study reports, and eCTD submissions. He is currently working as an Associate Data Manager at Piramal Clinical Research in Hyderabad, where his responsibilities include data entry, validation, query handling, report writing, and ensuring high-quality standards are met. He has a B.Pharmacy degree from Priyadarshini Institute of Pharmaceutical Education and holds skills in MS Office, data management software, and regulatory writing.

1. ASHOK KOTA
S/o K.Adinarayana
D.No.: 22-10-120
Lalapet, Rekhapalli Vari Street Mobile:+91-9966881979 / 9177226164
Guntur, Andhra pradesh Email: ashokkota10@gmail.com
PROFESSIONAL SUMMARY
1+ years of experience in the areas of Data Management and preparation of high quality
regulatory documents like Final Study Reports and Addendum Reports and having
experience in preparation of eCTD Reports. Dedicated & hardworking, zeal to learn & excel,
ready to take the assigned work as a challenge and fulfilling it with the best of my abilities.
WORK EXPERIENCE
 Working as a Associate Data management/Medical writer in Piramal Clinical
Research, Hyderabad from August 2013 to till now.
Roles and Responsibilities
· Coordinating with the programmers in creating the Database, User Acceptance Test
for Database
· Applies corrections and/or updates to the clinical database and appropriate documents
(original and/or working copies of CRFs for paper studies) that are identified through
query resolution, data entry, text review, site request, computerized validation, and/or
data importing.
· Understanding Study Protocol and Sop’s
· Data entry in In Form eCRF 4.6.
· Data Management Plan (DMP), Data Validation.
· Error free data with High quality standards.
· Discrepancy management - Query management.
· Estimation of Sample size in SAS 9.2
· Calculation of pharmacokinetic parameters in Phoenix WinNonlin 6.3
· Preparing, Compiling, Reviewing and Dispatching of ICH E3 reports as per the
guidelines, sops and sponsor requirements.
· Preparing high quality regulatory documents that meets ICH standards, project
timelines and client specifications
P a g e | 1 of 4

2. · Provide input to improving the effectiveness of the organization such as developing
new processes, systems and Customer relations
· Excellent mailing communication with Monitors and lead Data Managers
· Preparing the eCTD reports for the electronic Submissions as per the ICH M2 Expert
Working Group specifications.
· Manage multiple projects simultaneously, while adhering to stringent timelines
· Work in close association with PI and QA, QC & Bio-statistician while preparing the
Clinical study report.
· Preparing the Pharmacokinetic summary reports for clinical trails.
EDUCATIONAL QUALIFICATIONS
Course Institution Board/university Duration Marks
%
B.PHARMACY
Priyadarshini Institute of
Pharmaceutical Education
and Research,Guntur,A.P.
Acharya Nagarjuna
University 2009-2013 71%
INTER Sri Chaitanya Junior College.
Board of
Intermediate
Education
2007-2009 82%
SSC Kanna English Medium
School.
Board of Secondary
Education. 2006-2007 75%
PROJECTS HANDLED
 Phase I, Phase II & Phase IV summary reports
 Bioequivalence and Bioavailability Studies for several sponsors
 Pharmacokinetic Reports
TECHNICAL SKILLS
 Operating Systems : Windows 2007 & 2013.
 Application packages : Ms-Office, Phoenix WinNonlin
P a g e | 2 of 4

3.  Acrobat Adobe 9.0 standard.
STRENGTHS
 I am dedicated, Industrious and Optimistic.
 Adjustable to any environment.
 Team work.
OTHER SKILLS
 Faced USFDA audit at Piramal Clinical Research, Hyderabad on 08-19th Sep 2014.
 Faced Netherlands and France audit at Piramal Clinical Research, Hyderabad on 11-13th
June 2014.
 Faced USFDA audit at Piramal Clinical Research, Hyderabad on 16-20th June 2014.
 Faced different audits by Third party, Sponsors and Regulatory Authority
 Attended a one day workshop on BASICS IN CLINICAL RESEARCH & ICH-GCP
conducted at Don Bosco College of pharmacy.
 Attended a one day workshop on QUANTITATIVE STRUCTURAL ACTIVITY
RELATIONSHIP (Q.S.A.R.) STUDIES conducted at Chalapati institute of
Pharmaceutical sciences.
 Attended a workshop on “BasicsofGoodClinical Practice” held on 18 & 19 March
2014 at NIMS, Hyderabad.
 Participated in an international seminar at Chittinadu University Chennai.
 Participated In A National Seminar On Drug Regulatory Affairs At
JNTUUniversityHyderabad.
PUBLICATIONS
 Research article: ASHOK et al., have reported that sphingosomes: A Novel Vasicular
drug delivery system in IJPRBS, 2013; Volume 2(2): 305-312.
 ASHOK et al., have reported that UV Spectrophotometric method of Glimipride in
International journal of pharmaceutical research and review
P a g e | 3 of 4

4.  Review article: ASHOK et al., have reported that THE CYCLODEXTRINS in IJPRBS,
2013; Volume 2(2) : 291-304
PERSONAL PROFILE
Name : Ashok Kota
Date of Birth : 30-03-1992
Father Name : K.Adinarayana
Mother Name : K. Prasanthi
Marital Status : Unmarried
Languages Known : English, Telugu.
Permanent Address : K.ASHOK
S/o K.Adinarayana
Lalapet, Rekhapalli Vari Street
D. No: 22-10-120, GUNTUR.
Landline: +91–863–6646345
DECLARATION
I do hereby confirm that the information given above is true to the best of my knowledge.
Place: GUNTUR
Date:
(K.Ashok)
P a g e | 4 of 4