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Data Management Manager

San Diego, CA

Order: 53233

We are looking for a Data Management Manager to work in the La Jolla area for a Pharmaceutical company in the area. This position will lead and coordinate data management activities for multiple assigned projects related to the planning, execution, collection, and cleaning of clinical data. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.

ESSENTIAL FUNCTIONS:

  • Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.

  • Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.

  • Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.

  • Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.

  • Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.

  • Work with biostatisticians and SAS programmers to harmonize data collection, compile and maintain SAS data standards, including CDASH CRF collection, CRF specification guidelines, and edit check documents

  • Lead the completion of data management activities to meet project timelines and communicate status to respective team members.

  • Contribute to development of outsourcing strategies and relationships with outsourcing partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.

QUALIFICATIONS:

  • Bachelor’s degree in a related field required

  • Minimum of 7 years’ experience in a clinical research data handling environment with relevant practical pharmaceutical/biotechnology experience in protocol review/CRF design, EDC clinical study databases and data management.

  • MedDRA and WHO Drug coding proficiency is preferred.

  • Knowledge of SAS is desired.

Top Skills

  • Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.

  • Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.

  • Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.