MD JOSIMUDDIN
B. Pharmacy
Malda
Summary
Detail-oriented Clinical Data Management (CDM) professional with a Bachelor of Pharmacy and certification in Clinical Research and Clinical Data Management from LLRI. Possess a strong understanding of the clinical trial lifecycle, drug development process, and regulatory requirements, including ICH-GCP guidelines. Trained in end-to-end clinical data management processes, from study start-up to database lock, including CRF design, Data Management Plan (DMP), Electronic Data Capture (EDC) systems, data validation checks, discrepancy management, and query resolution. Experienced in maintaining accurate, high-quality, and regulatory-compliant clinical trial datasets. Have hands-on exposure to clinical database design, normalization concepts, data cleaning, SAE reconciliation, and medical coding using MedDRA and WHO Drug Dictionary. Familiar with CDISC data standards basics, risk-based monitoring (RBM) concepts, clinical data listings, and Clinical Study Report (CSR) preparation. Seeking an entry-level opportunity in Clinical Data Management or Clinical Data Operations to contribute to high-quality data management, regulatory compliance, and reliable clinical trial outcomes.
Overview
5
5
Certifications
3
3
Languages
Work History
Clinical Data Management Training
Learning Lab Research Institute
11.2025 - Current
- Completed structured training covering the complete Clinical Data Management workflow. Key training areas include:
- Clinical research fundamentals and drug development process, clinical trial protocol review and regulatory compliance.
- CRF / eCRF design and completion guidelines, Data Management Plan (DMP) development.
- Electronic Data Capture (EDC) systems and clinical databases, database design and normalization concepts (1NF, 2NF).
- creation of clinical databases for laboratory data management, data validation rules, edit checks, and discrepancy management, query generation, query tracking, and query resolution processes.
- Serious Adverse Event (SAE) reconciliation and safety data review.
- Medical coding using MedDRA and WHO Drug Dictionary.
- Clinical data review, data cleaning, and quality control, clinical data listings and Clinical Study Report (CSR) support.
- Introduction to Risk-Based Monitoring (RBM) and data quality management.
FINAL YEAR PROJECT: Teratogenic Effects of Drugs in Different Stages of Pregnancy. Conducted a research study evaluating...
Education
Pharmacy
Chaitanya (Deemed To Be University)
Telangana 04.2001 -
Skills
Clinical Data Management
Electronic Data Capture (EDC)
CRF / eCRF Design
Data Validation & Edit Checks, Query Management
Data Cleaning, SAE Reconciliation
Clinical Database Design, Clinical Data Review
Discrepancy Management, CDISC Standards (SDTM Basics)
MedDRA Coding, WHO Drug Coding
Clinical Trial Data Lifecycle, Database Lock Activities, Risk-Based Monitoring
Clinical Study Report Support
Friendly, positive attitude
Cross-functional teamwork
Prioritization and scheduling
Versatile
Effective decision-making under pressure
Accomplishments
- Achieved 100% scores in Clinical Research and Adverse Event Reporting certification programs.
- Scored 95% in ICH-GCP E6 (R3), demonstrating strong understanding of ethical and regulatory compliance.
- Maintained 100% adherence to safety reporting timelines during training activities.
- Gained exposure to more than 30 clinical research modules covering CRA, CRC, Pharmacovigilance, and Regulatory Affairs.
- Delivered zero critical documentation errors during case processing and safety data review exercises.
Certification
ICH Good Clinical Practice (GCP) E6 (R3) – Global Health Training Centre (Score: 95%)
Timeline
Clinical Data Management Training
Learning Lab Research Institute
11.2025 - Current
Pharmacy
Chaitanya (Deemed To Be University)
04.2001 -