Senior/principal Clinical Data Manager

Trzdev36

Cdm administrative support
Data cleaning and reviews
Query management
Provide project level CDM administrative support for study start up, conduct and closeout phases

Job Summary

  • Provide project level CDM administrative support for study start up, conduct and closeout phases.
  • Oversee day to day operational aspects of CDM for assigned projects, identify risks, and collaborate to mitigate them.
  • Drive adherence to AZ CDM standards and processes for data quality and consistency, and provide input for regulatory inspections/audits.

Matching Summary

Provide project level CDM administrative support for study start up, conduct and closeout phases.

Skills & Requirements

Must-have

  • CDM administrative support
  • data cleaning and reviews
  • query management
  • third party data reconciliation
  • study status reporting
  • collaboration with Data Management Vendor
  • oversight of data quality
  • compliance to Trial Master File

Nice-to-have

  • continuous improvement related to CDM
  • mentoring junior colleagues
  • ad hoc requests

Key Requirements

  • University or college degree in life sciences or related subject
  • Knowledge of Clinical Data Management
  • Experience in Biotech/Pharma/CRO industry
  • Understanding of Good Clinical Data Management Practices (GCDMP)
  • Experience with clinical databases, CDMS, and EDC
  • Experience in query management and reconciliation
  • Knowledge of CDISC standards
  • Knowledge of SQL, 4GL, VBA or R software

Work Rights

Not specified

Tailored Resume

Cover Letter