Clinical Data Manager (CDM)
ROLE DEFINITION & RESPONSIBILITIES
A Clinical Data Manager (CDM) oversees the design, collection, validation, and curation of clinical trial patient data. They design electronic Case Report Forms (eCRFs), author Data Management Plans (DMPs), build data validation edit checks, manage query discrepancies, and lead database lock protocols to guarantee audit-ready data for statistical evaluation.
SALARY INTELLIGENCE ROADMAP
LEARNING PATHWAYS
Clinical Data Principles & GCDMP Guidelines
Learn Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices.
eCRF Design & Validation Specifications
Create standardized visit schedules, forms, log fields, and draft dynamic validation edit check logic.
EDC Administration & Query Workflows
Execute UAT, review incoming clinical records, raise descriptive queries, and perform medical coding.
Reconciliation & Database Closure
Reconcile central laboratory data, coordinate with biostatisticians, and execute pre-lock audits.
CONNECTED ZANE PROED ACADEMY COURSES
Clinical Research & GCP Standards Masterclass
Become certified under international ICH-GCP regulatory parameters.
VERIFIED INTERVIEW PREPARATION
> Q: What key criteria must be fulfilled prior to authorizing a clinical trial Database Lock?
Before database lock: 1) 100% of subject visits must be entered in EDC. 2) All data queries must be resolved and closed. 3) Serious Adverse Event (SAE) reconciliation between clinical EDC and safety database must match. 4) External lab and vendor data must be reconciled. 5) Medical coding must be approved by medical monitor. 6) Principal Investigators must electronically sign all casebooks.
> Q: What is the function of a Data Management Plan (DMP)?
The DMP is the operational roadmap documenting all data handling procedures for a study, including database design specifications, data flow, edit check logic, discrepancy handling workflows, external data transfer agreements, quality control procedures, and final archive storage.