Urgent job openings for Clinical Data Specialist @ Covance

Job openings @ Covance Inc.

Post Name: Clinical Data Specialist

Education/Qualifications:

  • Bsc/Msc Life Sciences
  • BDS/BAMS
  • B pharma/M pharma

Experience:

  • Ability to maintain confidentiality of data and information during interactions with staff at all levels
  • Demonstrated computer literacy
  • Accurate keyboarding skills
  • Basic understanding of medical terminology
  • Understanding of ICH-GCP principles
  • 4+ years of relevant experience in CDM

Job Overview:

  • Work concurrently on multiple data management projects, with minimal guidance from line manager or experienced colleagues.
  • Support User Acceptance Testing (UAT) for validation (edit) programs as requested. Test data entry screens per data entry guidelines and Case Report Forms (CRFs) for selected projects
  • Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data Manager
  • Independently perform additional data cleaning tasks which includes logic checks using listings and reports as needed, SAE reconciliation, and identification of issues and data trends, EDC dataset QC, perform interpretations of compare output and provide feedback to Project Data Manager for resolution and database edits
  • Generate data complex data queries as directed by Manager/Project Data Manager with minimal guidance required from respective personnel
  • Conduct quality control processes including CRFs to database review
  • Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes
  • Provide guidance and training to Level 1 and new hires into the CDA role
  • Perform all tasks to relevant Covance and/or Sponsor SOPs, ICH or other regulatory guidelines in Data Management
  • Perform other duties as required by the Department

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