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Clinical Data Management (CDM)

Clinical Data Management (CDM)

Master Clinical Data Management from the ground up — covering all 5 phases of drug development, from discovery to post-marketing surveillance. Designed for pharma graduates, this practical program equips you with the skills, tools, and regulatory knowledge to become job-ready as a CDM professional. Learn by doing: real trial scenarios, hands-on system knowledge, and interview-ready expertise included.

₹10000

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Has discount
Expiry period 2 Months
Made in English
Last updated at Sat May 2026
Level
Intermediate
Total lectures 0
Total quizzes 0
Total duration 0 Hours
Total enrolment 0
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Short description Master Clinical Data Management from the ground up — covering all 5 phases of drug development, from discovery to post-marketing surveillance. Designed for pharma graduates, this practical program equips you with the skills, tools, and regulatory knowledge to become job-ready as a CDM professional. Learn by doing: real trial scenarios, hands-on system knowledge, and interview-ready expertise included.
Outcomes
  • 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
Requirements
  • Education: Bachelor's degree or diploma in Pharmacy, Life Sciences, Biotechnology, Microbiology, Biochemistry, Nursing, or a related health science field
  • Technical skills: Comfortable using a computer and basic Microsoft Office tools (Word, Excel). No programming or database experience required
  • Attitude: Strong attention to detail and a methodical approach to learning — CDM is a precision profession where accuracy is paramount
  • Industry knowledge: Basic familiarity with the pharmaceutical industry or clinical research is helpful but not mandatory — the program is designed to start from first principles
  • Device: A laptop or desktop computer with internet access to explore EDC system demos and regulatory resources referenced in the program

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