Sr. Manager, Clinical Data Management

San Francisco, CA | Full Time | Biostatistics and Data Management

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Job Description

Job Summary

The Senior Manager of Data Management will work closely with biostatistics, data management, and clinical operations colleagues to oversee the creation and maintenance of the CRFs and EDC systems.  In addition the manager will oversee the data management activities performed by the CRO. 

Responsibilities

  • Manages service providers to ensure the quality of deliverables and that timelines are met
  •  Liaise cross functionally with internal counterparts to ensure quality of deliverables and that timelines are met
  •  Contributes to technical infrastructure of Data Management and process improvement
  •  Manages Data Management related timelines.  Coordinates and synchronizes deliverables / milestones with the overall execution team timelines
  •  Responsible for building effective Data Management vendor relationships for all assigned studies.  Escalate issues with proposed solutions, as necessary
  •  Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions
  •  Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards
  •  Represent Data Management in team meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects
  •  Develops, applies and promotes consistent Data Management standards through standard processes and SOPs
  •  Other duties as assigned

Skills & Requirements

Education and Experience

  • Bachelor’s degree in Computer Sciences, Mathematics, Life Sciences with a minimum of 5 years of data management experience in the pharmaceutical or biotechnology industry, or MA/MS with 3 years of experience plus 1 year of people management experience
  • Oncology experience required
  • Hands-on experience with an Electronic Data Capture system
  • Hands-on study management experiences with Inform, RAVE, Oracle Clinical, or other related DM systems
  • Working experience with CDISC / SDTM preferred

Working Conditions

  • Office-Based position.  Some travel may be required.