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We are hiring a Sr. Clinical Data Manager

San Francisco Metro Area, CA

Posted: 10/31/2018 Job Type: Clinical Job Number: JN -102018-22952
Responsibilities:
  • Participates in the development, review and implementation of departmental SOPs, templates and processes
  • Supports budget and resource planning across assigned projects
  • Contributes to technical infrastructure of data management
  • Participates in CRO/vendor selection process for outsourced activities
  • May participate in department or cross-functional initiatives
  • Represents data management in study team meetings
  • Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
  • Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols)
  • Executes and/or distributes data management metrics, listings, and reports, as required
  • Oversight of data management CRO/service providers on assigned studies
  • Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
  • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
  • Proactively identifies potential study issues/risks and recommends/implements solutions
  • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial, able to work independently towards the assigned goal
  • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
Requirements:
  • Bachelors plus a minimum of 5 years of SENIOR-LEVEL DM (i.e., Sr. CDA) experience in the pharmaceutical or biotechnology industry or equivalent; depth and exposure to DM related tasks considered in lieu of minimum requirement
  • CRO management experience desired
  • Competence in SAS programming a plus
  • Prior oncology/hematology experience highly desirable
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