Senior Clinical Data Manager
San Francisco Bay Area
Permanent OR Contract
• Management and/or completion of CDM deliverables to meet project timelines for assigned studies - eg: Case Report Forms, DB specifications, eCRF development, user acceptance tests, edit checks specifications and programming, data management plans, AE/medication coding
• Monitors every aspect of data management deliverables quality from data collection design to database lock for assigned studies
• Serve as the data management subject matter expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables and resource requirements
• Manage and/or liaise with 3rd party vendors specifically related to data collection and analysis, and communicate project timelines
• Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers
• Contribute to the development and maintenance of CDM Standards with regards to the CDM Database environment and ancillary systems and CDM data handling practices and procedures.
• Participate in the evaluation, selection and/or implementation of new technology, new manual processes, integration of CDM activity with other departments
• Contributes to the review and further development of existing practices as well as the identification and adoption of new CDM practices and policies
• Provide training on SOP, WI and CDM practices both internally and externally to CDM.
• Stays current with industry trends in Data Management and participates in implementing relevant industry practices.
sologig - 19 months ago