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Master Clinical Data Management | Life Sciences & Healthcare

Master Clinical Data Management | Life Sciences & Healthcare

About This Course
Clinical Data Management (CDM) Course | 3-6 Months
Learn clinical research phases (I-IV) and CDM’s role in drug development.
Understand key regulatory bodies: FDA, EMA, DCGI & GCP guidelines.
Master clinical trial protocols, CRF design, and eCRF vs. paper CRF.
Gain skills in data management plans, data entry, validation & query resolution.
Hands-on training with top EDC tools like Medidata Rave, Oracle InForm.
Explore data validation, edit checks, discrepancy & audit trails.
Learn medical coding with MedDRA & WHO drug dictionaries.
Manage Serious Adverse Events (SAE) & pharmacovigilance basics.
Understand database lock, study close-out, data archiving & audits.
Optional software training: SAS, Excel, CTMS integration.
Career support: resume, interviews, CCDM® certification prep.
Ideal for life science grads & clinical professionals aiming for high-demand CDM roles.
What You'll Learn
  • Clinical research phases (I-IV) and CDM’s role in drug development.
  • Regulatory bodies: FDA, EMA, DCGI & key stakeholders in trials.
  • Good Clinical Practice (GCP), 21 CFR Part 11, and CDISC standards.
  • Designing clinical trial protocols, CRFs, eCRFs vs paper CRFs.
  • Clinical data management process: data entry, validation, and queries.
  • Hands-on experience with EDC systems like Medidata Rave, Oracle InForm.
  • Data validation, discrepancy management, and audit trails.
  • Medical coding using MedDRA and WHO Drug Dictionary.
  • Managing Serious Adverse Events (SAE) and pharmacovigilance basics.
  • Database lock, study close-out, archiving, and audit readiness.
  • Quality assurance with audits, SOPs, and continuous improvement.
  • Optional software training: SAS, Excel, CTMS integration.
  • Career guidance: resume, interview prep, and certification overview.
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