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Our client is hiring a Sr. 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 -112018-23139
Responsibilities:
  • Develop and implement strategic vision for data management (DM) group
  • Responsible for managing, planning and coordinating the activities of the Data Management group
  • Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
  • 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.

REQUIREMENTS:

  • Minimum of 10 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.
  • Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
  • Experience with SAS.
  • Excellent time management, ability to coordinate workload and meet established deadlines.
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