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Clinical Data Manager / Sydney

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Location: Sydney
Salary:Competitive salary
Clinical Data Manager
  • Opportunity for an experienced Clinical Data Associate / Data Manager to advance their career
  • Sydney HQ'd - offering flexible working
  • Involvement in end to end of the process
  • Company has rapidly growing Australia wide & global footprint
The role

Responsible for performing assigned data management activities, including database setup, discrepancy management, external data reconciliation, data reviews, interim analyses and database lock. 
  • Support the Senior Clinical Data Manager with all data management activities from study start-up to database lock
  • Review of Case Report Forms, Edit Checks, Data Management Listings, Query Listings for data cleaning
  • Lead training on electronic systems for the study including EDC and IRT system
  • Provide clear verbal or written communication and hands-on support to project team members and to sub-CROs/vendors related to CRF design, data quality and reporting of study results.
  • Ensure data integrity across projects following applicable regulatory standards, ICH, GCP and SOP.
  • Monitor data clean-up process, including where performed by sub-CROs/vendors, from study start-up through data archiving.
  • Manage activities including medical coding, developing data validation checks and managing database snapshots.
  • Prepare and distribute project status reports to project team and management.
  • Create and maintain project documentation, including, but not limited to, Data Management Plan, eCRF Completion Guidelines and validation specifications, and work instructions for assigned projects. Design and modify eCRF.
  • Work with study team and coordinate all data management functions.
  • A positive 'can do' attitude
  • Degree level qualification in relevant field
  • 2+ years’ experience in clinical data management within a pharmaceutical/biotech/CRO environment
  • Working knowledge of Clinical Database Applications such as EDC, IWRS and CTMS
  • Knowledge of clinical research, medical terminology/disease processes and clinical practice
  • Practical experience applying knowledge of GCP, ICH and other regulatory requirements
  • Strong clinical systems understanding
  • Experience with clinical data registries is preferable


How to Apply

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