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Our client is hiring a Sr. Manager/Associate Director of Clinical Data Management to be located in South San Francisco, CA!

San Francisco Metro Area, CA

Posted: 10/23/2018 Job Type: Clinical Job Number: JN -102018-22887

Responsibilities

  • EDC System Administration, including performing and/or overseeing Site and User accounts
  • Collaborate with IT and Clinical Quality Assurance on system validation
  • Participate in audits as Data Management and Systems Subject Matter Expert
  • Good understanding of clinical data flow
  • Proven Clinical Data Management experience (e.g. as a Lead Data Manager)
  • Create process maps and related documentation including documents supporting training development
  • Participate in vendor management, ensuring requirements are met and consistency
  • Accountable for end to end mapping of study systems per SMT process
  • Accountable for ensuring that data management services meet procedural, business and regulatory requirements
  • Coordinate with Lead Data Managers and Biometrics Leadership to deliver consistent, effective and efficient enablement services and partner with key stakeholders (project and function)

Requirements

  • Minimum 5 years experience in clinical research, within Clinical Data Management with a minimum of 5 years experience in system process experience
  • Knowledge of GCP/FDA/ICH regulations required.
  • Extensive knowledge of Clinical Trial systems (e.g. EDC, Clinical Trial Management Systems, eTMF, MedDRA and WHODrug, etc.)
  • Extensive knowledge of data management, clinical operations, safety operations, and clinical processes
  • Medidata Rave required, in addition Bioclinica Express and other EDC systems preferred
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