Jobs · Missouri

Corporate Clinical Data Management Job at ICON – Opportunities Across Bengaluru, Chennai & Trivandrum!

Meditechnika · Medicine, MO · 4 days ago
Full-time

About the role

ICON is hiring a CDC II for its Clinical Data Management team under the ICON Strategic Solutions (FSP) division. This Clinical Data Management Job is ideal for professionals with experience in clinical trials, data review, and regulatory compliance.

Responsibilities

  • Plan, coordinate, and perform risk-based clinical data review activities.
  • Define trial-specific data review requirements in collaboration with Trial Partners.
  • Cook up with programmers to establish data review tools.
  • Monitor and communicate data review progress to Clinical Trial Data Managers (CTDM).
  • Ensure timely completion of clinical data review deliverables.
  • Support process and toolkit improvement initiatives.
  • Drive risk-based data management approaches.
  • Review clinical datasets, listings, reports, visualisations, and analytics for completeness and accuracy.
  • Raise, manage, and resolve data queries using EDC/CDMS platforms.
  • Develop Data Management Manuals (DMM) and review plans.
  • Maintain clinical trial documentation and support data archival.
  • Perform data reconciliation and quality checks.
  • Contribute to dashboards and data visualisation activities.
  • Support audits, inspections, and regulatory compliance.
  • Aid with eCRF maintenance, validation specifications, and study procedures.
  • Track study metrics and communicate project status.
  • Investigate and resolve clinical data issues using root cause analysis.

Requirements

  • Bachelor’s degree in Healthcare or a related discipline.
  • Experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry.
  • Familiarity with Medidata, Oracle RDC, or similar clinical data management systems.
  • Knowledge of ICH-GCP guidelines and regulatory requirements.

Skills

  • Clinical Data Management
  • Clinical Trial Data Review
  • Clinical Research
  • Data Validation
  • Electronic Data Capture (EDC)
  • eCRF Management
  • Medidata
  • Oracle RDC
  • Data Reconciliation
  • Data Integrity
  • Risk Assessment
  • Data Visualization
  • Clinical Trial Documentation
  • Regulatory Compliance
  • ICH-GCP
  • Analytical Thinking
  • Attention to Detail
  • Cross-functional Collaboration
  • Communication Skills
  • Problem-solving

Pay

Commensurate with experience.

Schedule

Hybrid.

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