Course description

Clinical Data Management (CDM) is one of the most in-demand yet least formally taught functions in the pharmaceutical industry. Every drug that reaches a patient depends on the quality of its clinical trial data — and CDM professionals are the guardians of that quality.

This program is built specifically for pharma graduates who want to transition into CDM roles at pharmaceutical companies, CROs (Contract Research Organisations), and biotech firms. Whether you are a fresh graduate in pharmacy, life sciences, or biotechnology, or an early-career professional looking to specialise, this program gives you the structured, practical knowledge that employers actually hire for.

WHAT YOU WILL LEARN:

You will journey through all five phases of drug development — Discovery, Preclinical, Clinical Trials (Phases I–III), Regulatory Submission, and Post-Marketing — and understand exactly what CDM professionals do at each stage. You will learn how to design Case Report Forms (CRFs), manage an Electronic Data Capture (EDC) system, write and interpret a Data Management Plan (DMP), execute query management, perform medical coding using MedDRA and WHO Drug Dictionary, and prepare a database for lock.

You will also master the regulatory landscape: ICH E6(R2) Good Clinical Practice, 21 CFR Part 11, CDISC standards (CDASH, SDTM, ADaM), and how SDTM datasets are prepared for FDA and EMA submissions. By the end, you will understand the full lifecycle of clinical data — from the moment a patient visits a trial site to the moment a regulatory agency approves a drug.

WHY THIS PROGRAM:

✔ Written by a CDM and clinical research professional with hands-on pharma industry experience

✔ Covers all five drug development phases — not just the clinical trial phase

✔ Includes real-world scenarios from actual trial situations

✔ Each chapter includes knowledge checks and interview Q&A

✔ Immediately applicable — the skills in this program are used on Day 1 of a CDM role

✔ Aligned with industry standards: ICH, CDISC, FDA, EMA, GCP

WHO THIS IS FOR:

This program is ideal for pharmacy graduates, life sciences graduates, biotechnology graduates, and early-career professionals in clinical research, medical affairs, or regulatory affairs who want to build a formal, structured career in Clinical Data Management.

No prior CDM experience is required. A basic understanding of the pharmaceutical industry or clinical research is helpful but not mandatory — the program begins from first principles.

What will i learn?

• Explain all 5 phases of drug development and describe the specific CDM activities and deliverables at each stage
• Write and interpret a Data Management Plan (DMP) — the master governing document for clinical trial data
• Design and interpret edit checks (validation rules) for range, consistency, and completeness errors in clinical data
• Perform medical coding using MedDRA (adverse events) and WHO Drug Dictionary (medications)
• Apply CDISC standards: understand CDASH, map CRF data to SDTM domains, and interpret ADaM dataset structures
• Apply CDISC standards: understand CDASH, map CRF data to SDTM domains, and interpret ADaM dataset structures
• Design a well-structured Case Report Form (CRF) that aligns with protocol requirements and CDASH standards
• Navigate and operate Electronic Data Capture (EDC) systems including Medidata Rave and Oracle Clinical
• Manage the complete query lifecycle — from auto-query generation to site response, resolution, and SLA tracking
• Manage the complete query lifecycle — from auto-query generation to site response, resolution, and SLA tracking
• Lead a database lock process — completing the pre-lock checklist and coordinating across CDM, biostatistics, and medical teams
• Describe post-marketing CDM activities including Phase IV trials, PSUR reports, and Risk Management Plans

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