Clinical Data Management – Beginner to Advanced Mastery Program
Deep dive into advanced CDM topics including CDISC standards, data migration, and complex database design.
Duration
3 Months
Course Fee
₹6,499
Course Overview
This course provides advanced knowledge of clinical data management — from database setup and CDISC implementation to data validation and regulatory compliance. Ideal for professionals looking to step up in the clinical research industry.
Key Highlights
- Master CDISC (SDTM, ADaM, CDASH) Implementation
- Hands-on experience with EDC tools and CDMS platforms
- Learn risk-based monitoring and data migration
- Industry mentor support and career guidance
Course Syllabus
Role and Overview of Data Management in Clinical Trials
Understanding how data collection, processing, and quality assurance support clinical research integrity.
Data Collection Tools and CRF Design
Development and utilization of case report forms for systematic data entry.
Electronic Data Capture (EDC) Systems
Technologies that collect clinical data digitally to improve accuracy and efficiency.
Data Entry Standards and Double Data Entry
Best practices for minimizing errors and validating entered data.
Data Validation and Edit Checks
Techniques to identify and resolve inconsistencies or anomalies in data sets.
Query Management and Data Cleaning
Processes for addressing discrepancies through communication with trial sites.
Database Design and Relational Databases
Structuring clinical data repositories for secure, accessible storage.
Coding with MedDRA and WHO-DD
Standardizing adverse event and medical condition descriptions using established dictionaries.
Data Lock, Freeze, and Archival Processes
Finalizing and preserving clinical trial data for analysis and regulatory review.
Preparation of Data Management Plans (DMP)
Documenting procedures for managing data throughout a clinical study.
Quality Assurance and Risk-Based Monitoring
Ensuring data integrity via planned audits and focused oversight.
Regulatory Compliance and Audit Trails
Maintaining records of data changes to support transparency and inspection readiness.
Data Integration and Transfer
Combining and moving data securely between systems and stakeholders.
Reporting, Data Summaries, and Listings
Generating standardized reports used for decision-making and submissions.
Hands-on Practice with Industry Software
Practical application using commonly employed clinical data management systems.
Career Opportunities
Clinical Data Manager
Oversee data lifecycle from collection to submission in clinical trials.
Average Salary: ₹6–15 LPA
CDM Programmer
Build and maintain clinical databases with CDISC compliance.
Average Salary: ₹5–12 LPA
Clinical Research Associate
Monitor trial data and ensure regulatory adherence across sites.
Average Salary: ₹4–10 LPA
Eligibility
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field
- Basic understanding of clinical research and data principles
- Interest in pharmaceutical or CRO roles
Certification
Certificate in Advanced Clinical Data Management from Genez Learnings LLP. Recognized by industry professionals and validated for employment in CROs and pharma organizations.
What Our Students Say
Priya S
The Advanced CDM course gave me hands-on exposure to EDC tools and data validation — I secured a job within weeks!
Sharma
Perfect blend of theory and practice. The instructor's real-world examples made complex topics easy to grasp.
Dr. Anjali
An excellent experience. The course helped me move into a data management role at a leading CRO.
Ready to Transform Your Career?
Join hundreds of professionals who have successfully transitioned into clinical data management roles with our expert-led training programs.