Clinical Data Specialist, Biostatistics and Data Management

Boulder, CO or San Francisco, CA | Full Time | Biostatistics and Data Management

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Job Description

Job Summary

The Clinical Data Specialist of Data Management will work closely with biostatistics, data management, and clinical operations colleagues to oversee the creation and maintenance of the clinical trial database.  In addition, the Clinical Data Specialist will oversee the data management activities performed by the CRO and assist the lead Data Manager of the study.

Job Responsibilities

  • Manages service providers to ensure the quality of deliverables and that timelines are met
  • Responsible for building effective DM vendor relationships for all assigned studies.
  • Escalate issues with proposed solutions, as necessary
  • Manages DM related timelines with DM vendor
  • Coordinates and synchronizes deliverables / milestones with the overall execution team timeline
  • Represent DM in team meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of project
  • Liaise cross functionally with internal counterparts to ensure quality of deliverables
  • Assists in database set-up and migrations including performing Sponsor User Acceptance Testing
  • Accountable for the accuracy and completeness of the clinical data collected in a clinical trail
  • Enters and manages data queries in the EDC system that will be resolved at investigational sites
  • Reviews data listings and performs reconciliation activities as needed
  • Contributes to the development of Data Management standards and process documents

Skills & Requirements

Education and Experience

  • Bachelor degree with a minimum of 3 years of data management experience in the pharmaceutical or biotechnology industry, or MA/MS with 2 years of data management experience
  •  Oncology experience preferred
  •  Hands-on experience with an Electronic Data Capture system (e.g. RAVE, Inform, or other related DM systems)
  •  Experience with CDISC / SDTM preferred

Working Conditions

  • Office based position with some travel required