The Manager, Quality Control and Data Entry is a staff management position within the Clinical Research Management team at our phase one research clinic in Lincoln, NE. This position is responsible for managing the data workflow through Quality Control (QC) and Data Entry (DE) for studies, maintains timelines for client deliverables and ensures regulatory compliance.
This is a fulltime, salaried line management position which overseas the work product and is accountable for the people management of these two work teams. Additionally, this role collaborates with other departments and clinical sites and engages with Sponsors.
We seek an excellent communicator, people manager, and process manager who is well-versed in the data entry and data QC process of phase one clinical trial databases.
\n Essential FunctionsResponsible for staff management in accordance with the organization's policies and applicable lawsResponsibilities include interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employeesCommunicate and provide support/guidance to appropriate groups/staff as required to ensure established, revised and/or new processes are followed to ensure quality on-time/zero defect standardsPlan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and are compliant with regulatory and internal procedure requirements.Attend and participate in study specific meetings related to study set up, timeline production and management, and study statusMay be required to carry out study tasks, including but not limited to, complete QC review of source data and raw data for studies, performing accurate data entry, attending internal study initiation meetings to determine QC criteria and timelines for studiesWrite QC and DE SOPs and Procedure guides and participate in SOP and Procedure Guide ReviewsCreate and track metrics associated with QC and DE responsibilitiesPresent the QC processes to sponsors and auditorsLead Process Improvement initiatives to improve the quality of the source data Knowledge/Skills/Education/ LicensesBachelor's field in a related degree required.3+ years of professional experience in clinical research data work (phase one preferred)1-2 years supervisory or trainer/leader experience required.Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferredPrior task/project management experience involving staff planning and forecasting. Ability to manage multiple projects/priorities requiredHigh attention to detail requiredExcellent oral and written communication skills requiredExcellent organizational skills requiredProficiency in MS office applications required*Work experience may substitute for degree requirements
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