M Thirumalesh is seeking a position in clinical data management to gain further experience. He has 6 months of internship experience in clinical data management. His skills include working with Oracle Clinical 4.6.6, discrepancy management, editing check specifications, clinical trial phases I-IV, data entry and reconciliation, database design, and understanding regulations and guidelines. He held a clinical data programmer role previously and is looking to continue advancing his career in clinical research.
Resume for the post of Data Manager in Clinical Data Managements Department.
I am having more than 7 years of experience and looking forward for a job opportunity in the Delhi-NCR or for home based job.
Madhavi Kaushal
Mob. No:+91-8447133946.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
Resume for the post of Data Manager in Clinical Data Managements Department.
I am having more than 7 years of experience and looking forward for a job opportunity in the Delhi-NCR or for home based job.
Madhavi Kaushal
Mob. No:+91-8447133946.
Clinical Research|Clinical Research Organisation|Clinical Development of drugskeerthipriya197
Abiogenesis Clinpharm Private Limited is a Clinical Research Organization(CRO) having experience and expertise in Clinical development of drugs, Bio-similar, Vaccine and Devices from preclinical to Phase IV clinical trials involving different study populations and many therapeutic areas for Nutraceutical and Pharmaceutical Companies & Pharmacovigiance Companies in Hyderabad and Clinical Research Companies in Hyderabad. Our expertise team will ensure efficient project management in managing Clinical trial services in different areas like Cancer Clinical Research Services, Oncology Clinical trial, Pharmaceutical data management, Clinical Study data management, Vaccienceutical clinical Trials, Pre-clinical drug development, Bio-similar Clinical Trials, Cancer Clinical Research Services. We offered end-to-end service for organisation whether it may be single project or designing a full-service. We are ready to assist you in clinical trial management for Clinical trials in oncology new drug development.
The Pre-Anesthesia Evaluation Module is designed to manage the data and workflow of pre-anesthesia evaluation, either at the pre-admission testing visit or at the surgeon’s office. Medical history is collected from patients via a self-administered Tablet questionnaire, and available data regarding that patient is also downloaded from the EHR. This data is used to determine what testing is needed prior to anesthesia. This system can be used in the surgeon’s office, to help avoid anesthesia complications and help prevent canceled or delayed cases. A set of screenshots and an overview of the module can be reviewed via this downloadable PowerPoint presentation.
Presenting precisionFDA for the first time at the Precision Medicine Coalition in Washington, DC on February 24, 2016
Any views or opinions expressed here do not necessarily represent the views of the FDA, HHS, or any other entity of the United States government. Furthermore, the use of any product names, trade names, images, or commercial sources is for identification purposes only, and does not imply endorsement or government sanction by the U.S. Department of Health and Human Services.
The Inferscience introduce Infera, a clinical decision support engine that improves decision making, assisting clinicians to work more quick-witted. In this presentation, you can get the detailed information about this Advanced Clinical Decision Support System.
Report out: SMART Emergency Medical TeamsUS-Ignite
SMART Emergency Medical Teams will help inter-disciplinary
teams improve quality of transition-of-care, promote
situational awareness, and the efficacy of simulation
debriefing.
The Pre-Anesthesia Evaluation Module is designed to manage the data and workflow of pre-anesthesia evaluation, either at the pre-admission testing visit or at the surgeon’s office. Medical history is collected from patients via a self-administered Tablet questionnaire, and available data regarding that patient is also downloaded from the EHR. This data is used to determine what testing is needed prior to anesthesia. This system can be used in the surgeon’s office, to help avoid anesthesia complications and help prevent canceled or delayed cases. A set of screenshots and an overview of the module can be reviewed via this downloadable PowerPoint presentation.
Presenting precisionFDA for the first time at the Precision Medicine Coalition in Washington, DC on February 24, 2016
Any views or opinions expressed here do not necessarily represent the views of the FDA, HHS, or any other entity of the United States government. Furthermore, the use of any product names, trade names, images, or commercial sources is for identification purposes only, and does not imply endorsement or government sanction by the U.S. Department of Health and Human Services.
The Inferscience introduce Infera, a clinical decision support engine that improves decision making, assisting clinicians to work more quick-witted. In this presentation, you can get the detailed information about this Advanced Clinical Decision Support System.
Report out: SMART Emergency Medical TeamsUS-Ignite
SMART Emergency Medical Teams will help inter-disciplinary
teams improve quality of transition-of-care, promote
situational awareness, and the efficacy of simulation
debriefing.
Best Clinical Research Courses In India 2023-2024.pdfTrishalaDeshmane1
Get comprehensive and up-to-date Best Clinical Research Courses in India for 2022-2023. Improve your career with our industry-leading courses, taught by expert trainers. Gain hands-on experience with cutting-edge technologies.
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.