1. M Thirumalesh
Hyderabad,Telangana
+0091 9542714181
thirumaddela44@gmail.com
Clinical data management professional with 6 months internship experience in clinical data
management , seeking assignments to obtain a position in an organization that provides me an opportunity
to gain further exposure and experience in clinical research organization where I can use my skills and
expertise towards continued growth and advancement.
Clinical Data management skills
 Working experience on oracle clinical 4.6.6
 Discrepancy Management
 Preparation of Edit check specification document for validation and derivation procedure.
 Good knowledge of Clinical Trial Management System (CTMS) & all phases (Phase I to IV) of clinical trial.
 Creating DVGs, adding values to DVG, creating DVG subsets, activation of DVG’s and adding the activated
DVGs to questions
 Data entry, first pass, second pass, test data entry, reconciling the differences between the first pass and second
pass data entry and transfer the data from test data to production data entry.
 Freezing and unfreezing the data, locking the database by batch locking and manually locking the RDCIs and
RDCMs.
 Good knowledge of 21 CFR Part 11, Good Clinical Data Management Practice (GCDMP).
 Good comprehension of FDA and CDISC guidelines, International Conference of Harmonization/ Good Clinical
Practice (ICH GCP) guidelines.
 Knowledge of clinical Trial data like Demographic data, Adverse Events (AE), Serious Adverse Events (SAE)
and Laboratory data (Lab Data).
 Knowledge in understanding SOP's and CRF designing in MS-Word.
 Good in Data Base Designing, Validation and Derivation Procedure, Glib, Data Management in Oracle clinical
4.6.6.
CDM EXPERIENCE
JAN 2015 - present (6 months) : IDDCR Pvt. Ltd, HYDERABAD, INDIA
Department : CLINICAL DATA MANAGEMENT
Designation : CLINICAL DATA PROGRAMMER
Reporting to : Manager
Environment : ORACLE CLINICAL 4.6.6
Office tools : MS EXCEL, MS WORD, MS ACCESS
RESPONSIBILITIES
 Defining programs, projects and appropriate compounds assigned to the program.
 Creating organization units, planned studies and defining regions.
 Discrepancy Management
 Defining easy study design by creating intervals, clinical planned events, treatments and creating patient
positions and displaying the exited patients

2.  Maintain the investigator records by creating investigator records and assigning investigator to study
sites.
 Preparation of Edit check specification document for validation and derivation procedure.
Projects handled A DOUBLE BLINDED,PLACEBO CONTROLLED ,RANDOMIZED, SINGLE -
DOSE, SAFETY AND PHARMACOKINETIC STUDY OF ASCENDING DOSES OF
ABC, 001 IN HEALTHY VOLUNTEERS
Jan 2013–May 2014(1 year) : RKLK COLLEGE , SURYAPET
Reporting to : HOLD
Designation : FACULTY
Department : PHARMACEUTICS
EDUCATION
Academic
2015 : M.PHARMACY
PHARMACEUTICAL ANALYSIS
VIKAS COLLEGE OF PHARMACY. SURYAPET, TELANGANA
2014 : BACHELOR OF PHARMACY
Aff..OSMANIA UNIVERSITY, INDIA.
CERTIFICATION : DIPLOMA IN CLINICAL DATA MANAGEMENT ( IDDCR)
Achievements & Personal skills
 Participatedas delegate andpresenteda poster entitled“SMOKING CESESSIONAID”inAnurag college of
B.Pharmacy.
 Participated in many seminars during study
 Developed skills in handling projects at individually covering all the phases successfully meeting
towards deadline, which included choosing of project, literature survey, design, implementation,
testing.
 Being part of team of CDM projects was effective discussing with clients and their requirements
clearly. Coordinating team, explaining and negotiating with requirements and involved in leading the
whole support project on a successful track with client appreciation for the team.

3. PERSONALDETAILS:
Date of Birth : 13-07-1992
Gender : Male
Marital Status : Unmarried
Nationality : Indian
Languages known: English, Telugu, Hindi
Address : H.No: 1-4-249/98/B
Balaji Nagar
Suryapet
Nalgonda
Telangana-508213
DECLARATION:
I hereby declare that all the details furnished herewith are true to the best of my knowledge. The Reference
and Originals willbe presented when attending the interview or on demand.