Summary
Overview
Work History
Education
Skills
Certification
Strengths
Projects & Recognitions
Declaration
Timeline
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Rajkumar Jangala

Warangal

Summary

Detail-oriented Medical Data Entry Supervisor with proven expertise in clinical trial management and pharmacovigilance. Strengths in team leadership and process optimization ensure high data accuracy and compliance.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Medical Data Entry Supervisor

Staffingly.Inc
Hyderabad
05.2023 - Current
  • Supervised data entry team, ensuring accuracy and efficiency in processing tasks.
  • Developed training materials and conducted sessions for new data entry staff.
  • Implemented quality control measures to maintain data integrity and compliance.
  • Coordinated daily workflows to optimize team productivity and resource allocation.
  • Assisted in troubleshooting software issues to minimize downtime for the team.
  • Monitored performance metrics and provided feedback for continuous improvement efforts.
  • Collaborated with management to streamline data entry processes across departments.

Education

M.Pharmacy -

Vaagdevi College of Pharmacy
Warangal
06-2024

B.Pharmacy -

Vaagdevi College of Pharmacy
Warangal
08-2021

Intermediate -

Vishwa Junior College
Warangal
07-2017

SSC -

Govt.High School Krishna Colony
Warangal
04-2015

Skills

Domain skills

1 Clinical trial management:

  • Knowledge of drug development (Phase I-IV) in clinical trials
  • Clinical trial monitoring (CRA) and responsibilities of the monitor, CRA, CRC, investigator, and sponsor
  • ICH-GCP - 13 core principles
  • Difference between ICH-GCP and Indian GCP
  • Informed consent process, reporting (AE, SAE)
  • New drug and clinical trial rule, 2019, CDSCO
  • Knowledge of GCP and ICH guidelines, including a basic understanding of regulatory requirements for clinical research and pharmacovigilance
  • Good understanding of essential documents and trial master file

2 Pharmacovigilance

  • ADR, serious adverse reaction, SUSAR, SAE, MedDRA, risk management, ADR monitoring, narrative reports, and GVP modules
  • ICSR, SAE reporting timelines, ICH-E2a, E2b, E2c guidelines
  • PSUR, DSUR, Volume 9A, CIOMS Causality Assessment, Signal, Frequency of ADR, De-challenge-challenge
  • Basic knowledge on Oracle Argus Safety Database, data entry, case processing, MedDRA coding, and SAE narrative writing

3 Medical writing

  • Creating the documentation that regulatory agencies require in the approval process for drugs
  • Clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures, and summary documents
  • Knowledge of the Common Technical Document (CTD)

Certification


Completed Advanced Certified Course in Clinical Research from Gratisol Labs.
Completed certification in Good clinical practice from NIDA Clinical trials network.
Completed certification in Introduction to Clinical Research from The Global Health
Network
Completed certification in ICH GCP E6 (R2) from The Global Health Network.
Completed certification in Data Management for clinical research studies from The Global
Health Network.
Completed certification in The Study Protocol from The Global Health Network

Strengths

  • Cool-minded and positive thinking under pressure conditions
  • Friendly attitude with everyone
  • Disciplined and hardworking

Projects & Recognitions

  • Participated in a poster presentation at Vaagdevi College of Pharmacy on green chemistry
  • Major project: Role of Phytochemicals in Wound Healing and their Invitro
    characterization and properties.
  • Minor project: Review article on computer-aided drug designing (CAD)
  • Qualified for the GPAT exam with an all-India rank of 449

Declaration

      I here by declare that all the information above is true and to the best of my  knowledge.

Timeline

Medical Data Entry Supervisor

Staffingly.Inc
05.2023 - Current

M.Pharmacy -

Vaagdevi College of Pharmacy

B.Pharmacy -

Vaagdevi College of Pharmacy

Intermediate -

Vishwa Junior College

SSC -

Govt.High School Krishna Colony
Rajkumar Jangala