Clinical Data Management training — job-ready skills
A focused program covering database design, EDC workflows, edit checks, query resolution, SAE reconciliation, database lock and audit-ready documentation. Hands-on labs and real case exercises prepare you for CDM roles in CROs, pharma and healthcare organisations.
Program Curriculum
Module 1: Study Start‑Up Phase
- Protocol and SOPs Overview
- Introduction to Clinical Data Management
- CDM Team Roles and Responsibilities
- Data Management Plan (DMP)
- Case Report Form (CRF) Design and Development
- CRF Annotation and Mapping to Standards
- Overview of Data Capture Methods (Paper vs. EDC)
- Introduction to EDC (Demo/Walkthrough)
- Data Transfer Agreements (DTA, vDTA)
Module 2: Study Conduct Phase
- Data Entry and Double Data Entry Best Practices
- Edit Checks: Concepts and Rule Writing
- Data Validation Procedures and Workflow
- Discrepancy Management and Query Resolution
- SAE Reconciliation Process
- Introduction to Medical Coding
Module 3: Study Close‑Out Phase
- Database Locking and Freezing Procedures
- Data Management Close‑Out Plan / Interim Lock Plan
- Data Reconciliation and Quality Control
- Data Storage, Backup, and Archival Processes
- Final Documentation and Audit Trail Management
Tools & Software Covered
- Electronic Data Capture (EDC) systems — overview and demos
- CTMS basics and TMF/eTMF walkthrough
- Common data reconciliation tools (Excel, SQL basics)
- Overview of Edit-check engines and validation workflows
Program Benefits
Hands‑On EDC Exposure
Practical EDC labs including case book‑in, query handling and reconciliation exercises.
Quality & Compliance Focus
Learn best practices for audit readiness, documentation and regulatory compliance.
Career Support
Resume & interview prep, mock assessments and introductions to hiring partners.
What You Will Learn
- How to design and annotate CRFs and map to data standards.
- Implement edit checks, validate data and manage queries.
- Perform SAE reconciliation and prepare for database lock.
- Assemble audit‑ready documentation and follow DMP guidelines.
- Use EDC/CTMS tools and perform data reconciliation workflows.
Career Pathways & Job Roles
Roles you can target after this program:
- Clinical Data Coordinator
- Clinical Data Associate
- EDC Specialist
- Query Management Specialist
- Data Validation Analyst
- Database Lock Coordinator
- Clinical Data Manager
- CDM Quality Analyst
Employers
Pharma companies, CROs, hospitals, biotech and data management vendors.
Career Growth
Progress from Coordinator → Associate → Manager → CDM Lead.
Salary Outlook
Competitive packages with faster growth for certified and experienced professionals.
Assessments & Capstone
- Module-wise quizzes and practical EDC exercises.
- Midterm practical assessment focused on edit-checks and reconciliation.
- Final capstone: end-to-end CDM project covering CRF design → data capture → query management → database lock.
Frequently Asked Questions
Do I need prior experience?
No — the program starts with fundamentals and progresses to advanced CDM topics with hands-on labs.
Will I get hands-on EDC access?
Yes — students receive guided access to lab instances or simulated EDC environments for practice.
Is placement assistance provided?
Yes — resume support, mock interviews and introductions to hiring partners are included.
Begin your journey in Clinical Data Management
Join the next CDM batch with hands-on EDC training, query resolution practice and placement support.