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Title:Contract- Clinical Data Manager
Location:CA - South San Francisco

Candidate will interact with various functional groups to locate and organize required documentation.

  • First and second pass data entry of CRFs into Oracle Clinical.
  •  Clinical review of CRFs, and data listings.
  •  Processing data clarification forms.
  •  QC auditing of clinical databases: comparing CRFs to SAS listings from Oracle Clinical, Integrated Review listings to original SAS dataset listings or SAS PROC COMPARE listings.
  •  Manage transfer of CRFs from CRO vendors to Document Management team.
  •  Maintain and organize data management working files.

  • Knowledge of and experience with relational databases, data processing, quality control and auditing procedures.
  • Familiarity with GCP, ICH and FDA regulatory requirements as they apply to clinical data management.
  • Oracle Clinical experience highly desired.
  • Strict attention to detail.
  • Strong written and verbal communication skills.
  • Ability to multi-task in a dynamic environment.
  • Bachelor’s degree in biological or health-related field desired. Knowledge of medical terminology required
  • 3-5 years CDM experience.

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