Clinical Data Manager II
The Ascent Services Group - Brisbane, CA

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Clinical Data Manager IINorthern CA areaThe Clinical Data Manager IIs primary function is to provide data management support to new and ongoing clinical studies in a clinical/drug programs. The CDM II also provides clinical data management guidance to cross-functional team members in support of clinical trials and is the CDM representative on assigned clinical project/protocol teams.Responsibilities• Management and/or completion CDM deliverables to meet project timelines for assigned studies - eg: Case Report Forms, DB specifications, eCRF development, user acceptance tests (UATs), 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• 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 Company departments • Participate in the review and further development of existing practices as well as the identification and adoption of new CDM practices and policies (eg Standard Operating Procedures (SOP) and Work Instructions (WI))
Education and Experience• BA/BS highly desirable; relevant experience may substitute for university degree.• 5-8 years of experience in CDM, with responsibility for all aspects of Clinical Data Management for several clinical trials. • Must have hands-on/operational experience in CRF design, database specification and query management.• Worked on cross-functional teams in a clinical environment, with a diverse group of professionals• Managed more complex projects and/or multiple projects, with multiple tasks and deliverables, spanning several months. • Lead projects requiring participation and contributions from diverse group of professionals of various levels

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