Principal Clinical Data Associate

The Principal Clinical Data Associate ("CDA") will have experience in all required areas of a Senior Clinical Data Associate. The Principal CDA is responsible for all data review associated activities for a clinical study. The Principal CDA may provide oversight to other CDAs and may assist the Lead with additional data management activities. Responsibilities:Exceed expectations and responsibilities of a Senior Clinical Data AssociateMay serve as the Lead Data ManagerMay assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documentsPerform user acceptance testingMay assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.)Review eCRFs in the database to ensure data consistency and completenessPerform manual data review and data listing review as defined on assigned studiesReview and respond to answered queries by the site and issue re-queries as neededGenerate manual queriesCommunicate potential data issues to the appropriate data management personnelPerform reconciliation of SAEs and external vendor data as required for assigned studiesIdentify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to addressPerform user account managementCollect and report on study metricsPerform data entry or quality control review of local lab dataPerform Quality Control reviewPerform EDC archival tasksServe as subject matter expertProvide training and mentoring for other Clinical Data AssociatesStandard Operating Procedures (SOPs)Strong understanding of departmental and company procedures; ability to guide others on proceduresParticipate in the development and revision of department SOPsBusiness DevelopmentMay support the business development process; RFI completion, proposal development, bid defense participation, attendance at industry/scientific meetings, etc.Additional ResponsibilitiesPerform other duties as requested by managementParticipate in data management candidate interviews Qualifications: Minimum of 7 years direct data management experience in pharmaceutical development or CRO environmentBachelor's Degree preferred. Work experience may be substituted for degreeWorking knowledge of CDASH standardsExcellent oral and written communication skills, organizational skills, and attention to detail are required

Company Description:Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.