Job Details

  • Title: Clinical Data Manager
  • Code: RCI-GILD-06286
  • Location: Foster City California (CA) 94404
  • Posted Date: 05/15/2019
  • Duration: 12 Months
  • Status: Open
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  Job Description

  • Work collaboratively with global, cross-functional study management teams to support post-marketing studies primarily in Korea and may also support studies in other regions
  • Provide vendor oversight, communicating expectations for study timelines and data quality
  • Provide CDM input during CRO selection process in order to select appropriate CRO by reviewing RFP (request for proposal to CRO) and CRO contract, or by attending CRO selection meeting
  • Review study protocols
  • Ensure completeness, accuracy, and consistency of clinical data and data structure through the creation and review of:
    • Case Report Forms (CRF) and CRF completion guidelines
    • Electronic Data Capture (EDC) requirements and specifications
    • Clinical Data Management Plans
    • Data Validation Plans
    • Data Quality Review Plans
  • Provide appropriate guidance to CRO DM personnel to resolve data/query related issues raised by CRO during day-to-day CRF data cleaning
  • Ensure adherence to processes and local country regulations
Essential skills and experience:
  • Demonstrates proficiency in leading studies/projects with little supervision
  • Experience working on global cross-functional teams
  • Excellent verbal and written communication skills in English
  • Experience working with EDC systems
  • Understanding of Good Clinical Practice
Preferred skills and experience:
  • Experience with post-marketing studies
  • Experience with Korean Post Marketing Surveillance studies
  • Understands Korean regulations
  • Korean written and verbal skills
  • Experience with DreamCIS EDC system
  • Experience in anti-viral therapeutic areas (HIV, HCV, HBV)
  • Vendor management experience
Education and experience:
  • 3-5 years experience and a BS degree