Thursday, June 23, 2011

Job : Clinical Data Coordinator 1

Job Title : Clinical Data Coordinator 1
Company Name : Covance CRO
Locations : India, Brisbane, Melbourne, Canberra, Sydney, Beijing, Canada, Shanghai, Germany, Hong Kong, Korea, New Zealand, Singapore, Taiwan, Tokyo, USA - Nationwide

Qualification : University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

Experience : Minimum one (1) years relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
• Demonstrated time management skill and ability to adhere to project productivity metrics and timelines
• Demonstrated ability to work in a team environment and collaborate with peers
• Demonstrated interpersonal skills.
• Good oral and written communication skills

Work Profile :
  • Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or implausible data
  • Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database
  • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
  • Assist with the reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
  • Assist with the aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
  • Assist in the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities
  • Support the training of project staff on project-specific, global, standardized data management processes
  • Perform other duties as assigned by management.
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