Senior Clinical Data Associate
Job Description
Responsibilities: Exceed expectations and responsibilities of a Clinical Data Associate May assist in the creation of the DMP, eCCGs, Edit Check Specifications, data review listing specifications and other start-up documents Perform user acceptance testing May assist with EDC module integrations/setup (ePRO, Randomization, Dispensing, etc.) Review eCRFs in the database to ensure data consistency and completeness Perform manual data review and data listing review as defined on assigned studies Review and respond to answered queries by the site and issue re-queries as needed Generate manual queries Communicate potential data issues to the appropriate data management personnel Perform reconciliation of SAEs and external vendor data as required for assigned studies Identify data trends and report inconsistencies to applicable data management personnel; collaborate to develop and implement actions to address Perform user account management Collect and report on study metrics Perform data entry or quality control review of local lab data Perform Quality Control review Perform EDC archival tasks Standard Operating Procedures (SOPs) Strong understanding of departmental and company procedures; ability to guide others on procedures Qualifications: Minimum of 3 years direct data management experience in pharmaceutical development or CRO environment Bachelor’s Degree preferred. Work experience may be substituted for degree Working knowledge of CDASH standards Excellent 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.