1. CURICULUM VITAE
Email: munnacharles@gmail.com
M. Charles Ravi Kumar Mobile: +91-9985478083, 9618204640
CAREER OBJECTIVE:
To pursue a challenging career in the field of Clinical Research in progressive way that gives
me scope to update my knowledge & skills to be a part of the team that excel in work towards
the development of the organization and gives me satisfaction.
EXPERIENCE:
Present working as a Bio-Statistician at Actimus Bio Sciences, Vishakhapatnam from
14 April 2014 to Till today.
Worked as Clinical Research SAS Tutor at Lara Technology Solutions at Hyderabad
from 03 Nov 2013 to 12 April 2014.
Worked as DMPK Scientist at Clinsync, Hyderabad from 02 Nov 2011 to 02 Nov
2013.
Worked as a Assistant Professor at MRR College of Pharmacy from 2009-2011.
PROFSSIONAL EXPERIENCE:
Hands on Experience on Pharmacokinetic analysis & statistics on Phoenix
WinnoNline Software.
Pharmacokinetic Analysis & Statistical Analysis for Fully Replicate Design and
Partial Replicate Design.
Sample size determination for Clinical studies.
Preparation of Study Design.
Pharmacokinetic Analysis & Statistics for Parallel cross over, Two way cross over,
Blind studies, Three way cross over and Four way cross over Study Designs.
Had an experience in generation of Randomization for Cross over partial replicate,
fully replicate and parallel studies for BA/BE studies and Clinical Bioequivalence
studies.
Clinical SAS programming for Clinical Trial Safety data.
Preparation of Derived DATA Sets according SDTM (CDISC).
Preparation of Tables, Listing and Graphs on SAS.
Preparation of AE table according to AdaMs Guidelines.
Review of SAS code according to Specifections.
2. Preparation of SAP for Clinical BE studies and Clinical Trials.
Preparation of Pharmacokinetics Study Report (PK Report).
Preparation of eCTD Report for Sponsor submission.
Compilation of Project documents of Trial master file after completion of project.
Had a good experience in generation of listing, tables and graphs for BA/BE studies
and Clinical trials studies on SAS software.
Preparation of Study Design, Wash out time, Sample time point for Project Protocols.
Internal Quality control activity during project.
Well Trained in ICH – GCP, Basic Life Support and Schedule Y on December 2011.
Participated in Weekly Meeting with Team Lead, Co-workers to discuss about the
work progress and queries regarding Project.
ROLES AND RESPONSIBILITIES:
Generation of Randomization Schedule and Randomization Chromatogram on SAS
software for clinical trial studies and Clinical BE studies.
Preparing The Metadata According to SDTM (CDISC) guidelines.
Extensively involved in preparation of Tables, Listings and Figures (TLF’s) by
Through AdaMs on SAS software for BA/BE studies and Clinical BE studies.
Sample size determination for BA/BE studies and Clinical BE studies.
Preparation of Pharmacokinetic Parameters for BA/BE studies, Study state studies
and Clinical BE studies.
Preparation of Pharmacokinetic data on Phoenix WinnoNlin software.
Preparation of Graphs, Plasma table, NCA Analysis, Pharmacokinetic table, Ratios
table, Kel charts, Bioequivalence table.
Preparation of Descriptive Statistics.
Preparation of ANOVA on GLM and Mixed procedure through SAS.
Preparation of Input sheet for Pharmacokinetic Analysis Clinical trial studies and
Clinical BE studies.
Preparation of Statistical Report for BA/BE studies.
In process Quality Control of Project files for BA/BE studies.
Review of Trial master file during the project.
Review of Pharmacokinetic data.
Maintenance of log books and training files.
Preparation & Review of eCDT Report for BA/BE studies.
3. Preparation of Metadata Derived data sets through SDTM (CDISC).
Preparation & Review of Protocol for BA/BE studies and Clinical BE studies.
Preparation & Review of Synopsis for BA/BE studies and Clinical BE studies.
Preparation & Review of Case Report Form (CRF) for BA/BE studies and Clinical
BE studies.
Preparation & Review of Clinical Study Report (CSR) for BA/BE studies.
AREAS OF INTREST:
Pharmacokinetics
Bio-Statistician
Clinical SAS Programmer
SDTM ( CDISC)
EDUCATION QUALIFICATION:
SAS Certification from SAS Institute at Aug 2013.
MSc Statistics from Sikkim University , Gangtok, Sikkim – 2012
M. Pharmacy (Pharmacology) from Sri Venkateshwara University, campus Tirupati,
Andhra Pradesh. – 2009.
B. Pharmacy from PRRM College of Pharmacy at Kadapa, Andhra Pradesh- 2007.
PROJECTS:
M. PHARMACY PROJECT:
Comparative Bio-Equivalence study of Venlafaxin Hydrochloride on human healthy
volunteers. At CR Bio science, Taarnaka, Hyderabad, Andhra Pradesh.
M. Sc PROJECT:
Comparative Bio-Equivalence study of Pharmacokinetics of Metaxlone on human
healthy volunteers, At Actimus Bio Sciences, Vishakhapatnam.
B. PHARMACY PROJECT:
Project was done on Preparation and evaluation of Chitosan Microcapsule containing
Refampicin drug at PRRM College of Pharmacy at Kadapa, Andhra Pradesh.
TECHNICAL SKILLS:
M. S. Office, Advance Excel, Phoenix Winnolin, SAS.
PERSONAL SKILLS:
Comprehensive problem solving abilities, excellent verbal and written communication
skills, Ability to deal with people diplomatically, ability to work under stress,
willingness to learn and Team facilitator.
4. PERSONAL INFORMATION:
Name : Munnangi. Charles Ravi Kumar
Date of Birth : May 5th 1979
Nationality : Indian
Marital status : Married
Gender : Male
Languages known: English, Telugu and Hindi
Permanent address: M. Charles Ravi Kumar, H no: 30/70,
Revenuquaters, Nandyal, Kurnool Dist,Andhra Pradesh.
Current Address: M. Charles Ravi Kumar
H No: 5-2-84, Ashok Nagar,
Peda Valtair, Vishakhapatnam.
DECLARATION:
I do here by declare that all above given information are true to the best of my knowledge and
belief.
Date:
Place: Hyderabad M. Charles Ravi Kumar