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Our client is hiring a Director of Clinical Data Management to be located in San Diego, CA!

San Diego Metro Area, CA

Posted: 11/28/2018 Job Type: Clinical Job Number: JN -112018-23138
Responsibilities:
  • Ensure that the Data Management group is aligned with business objectives and complies with FDA requirements.
  • Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
  • Manage the clinical data managers within the organization.
  • Work closely with CROs to prepare and ensure proper execution of data management plans; manage data management projects from beginning to end.
  • Work closely with Medical Directors, Medical Monitors, CTAs, and CRAs in planning and execution of DM activities regarding clinical studies.
  • Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.
  • Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
  • Participate in cross functional team meetings as requested.
  • Coordinate with SAS programmers to create and validate database design and edit check specifications.
  • Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.

QUALIFICATIONS:

  • Requires a Bachelor s degree.
  • Minimum of 8 years experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management and at least 2 years experience managing others.
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