Ensures data management activities and deliverables for area(s) of responsibility are completed in line with business requirements and company objectives.
Oversees service providers to perform core data management functions including CRF, edit check development, user acceptance testing, data cleaning, reviewing listings, and database locking procedures.
Evaluates and approves service level agreements.
Evaluates and makes recommendations related to inter- and intra-departmental processes in order to identify and implement efficiencies and quality improvement measures.
Managers require at least five years of data management experience in a pharmaceutical or clinical research setting.
Bachelor's Degree or higher or equivalent amount of combined educational and work experience is required. Exceptional candidates may be considered with less years depending on experience and education.
Experience with computerized clinical data management systems. Thorough understanding of the drug development process, clinical trial methodology, GCP regulations, and data management principles.
Experience in data management, systems, technical and outsourcing.
Experience in directly managing/overseeing service providers is desired. CCDM is preferred.
Knowledge of SAS and database programming, systems integration experience and understanding of CDASH and CDISC.