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Title:Manager, Data Management
Salary:Open
Experience:4-6
Location:CA - South San Francisco

Description:
Under general direction, responsible for the planning, implementation and overall direction of executing/achieving clinical trial data management activities including CRF/eCRF design, database development, validation programming, discrepancy management, and database release. Interacts with Biostatistics, Clinical, and Regulatory personnel on a daily basis to ensure compliance with protocols, SOPs, and overall clinical objectives. Evaluates and analyzes clinical data as appropriate.

Responsibilities:
  • Provides study-specific outsourcing specifications for RFPs
  • Oversees work done by CROs, central labs and other vendors chosen for clinical trials
  • Supervises CRO relationships and performance
  • Working with study team and CRO to ensure the highest quality of the clinical data
  • Oversees the development and maintenance of the components of the study Data Management Plan (DMP). The DMP includes Case Report Form (CRF), CRF completion guidelines, SAS annotated CRFs, data handling plan, data entry review guidelines, edit check specifications, data transfer specifications, and database audit plan
  • Manage study-related activities including working with CRO to review outgoing DCFs; facilitate dictionary coding process; and reconcile external data streams against the clinical database
  • Provide specifications for developing eCRFs in EDC studies
  • Participate the eCRFs user acceptance test
  • Conduct vendor data management function inspections
  • Delegate data management tasks to consultants or service providers
  • Provide technical review and guidance to the development of data management deliverables
  • Contribute to the development and implementation of departmental policies, standards and process improvement initiatives

Requirements:
  • BA in scientific discipline, MS preferred
  • 4-6 years clinical data management experience, performing general data management.
  • Previous management of projects and personnel is required.
  • Knowledge of pharmaceutical clinical drug development life cycle.
  • Knowledge of FDA requirements and good clinical practices.
  • Strong technical skills and knowledge of data management database systems and relevant computer languages (SAS, SQL)
  • Ability to interpret, evaluate, and clean clinical data
  • Ability to communicate, plan, and organize data issues to clinical project team
  • Ability to develop, communicate, negotiate, and implement solutions to data issues and processes to yield more accuracy and greater productivity
  • Strong leadership and communication skills coupled with the ability to effectively manage multiple projects and timelines
  • Knowledge of implementing clinical studies using EDC tools
  • Project management and planning skills
  • Ability to develop data management processes and training
  • 6 years clinical data management experience with a strong technical background preferred.
  • Previous management of projects and personnel is required.
  • Knowledge of FDA regulatory requirements preferred.

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