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Senior Clinical Data Manager

San Mateo Metro Area, CA

Posted: 07/03/2019 Job Type: Clinical Job Number: JN -072019-25181
Our biopharmaceutical client is recruiting for a Senior Clinical Data Manager to join their growing team.

The Senior Clinical Data Manager will support the Data Management group from study start-up through database lock and clinical study report.
  • Partner with clinical study team to create the clinical data management plan (CDMP), including CRF development, data validation specifications, data transfer specifications, and clinical listings and reports.
  • Oversee interactions with outside vendors on collection, transmittal, reconciliation and transfer of study specific data.
  • Vendor management and oversight of all CRO data management activities to ensure proper execution of data management plans.
  • Participate in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM
Education/ Training:
  • Bachelor degree in Life Sciences, Computer Sciences, Mathematics, or health-related field
  • 5 plus years of experience in the pharmaceutical or biotechnology industry
  • Experience managing Clinical Research Organizations (CROs)
  • Solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
  • Well-rounded technical skills (EDC systems, CDM systems, etc.)
  • Knowledge of industry standards (CDISC, SDTM, CDASH)
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