Clinical Data Associate

Job Description:

• Perform comprehensive data management tasks including data review, query generation, and query resolution
• Support all study phases: Start-up, Execution, Database Lock, and Close-out
• Perform ongoing data reconciliation across all data streams, including EDC, imaging, and third-party vendors
• Review discrepancy/edit check output and validation listings per the Data Management Plan
• Resolve answered queries and re-query where appropriate
• Receive and reconcile imaging data
• Manage eCRF freeze/lock activities
• File documentation in the Trial Master File
• Support study closeout and archiving activities, including QC of subject/site CRFs
• Serve as a proficient day-to-day user of the EDC system, including form/field configuration awareness, user access, and data export
• Generate EDC reports to track data cleaning progress and outstanding queries
• Perform DM quality review and internal QC checks
• Support EDC-related testing during study build and amendments
• Maintain Power BI dashboards and reports tracking data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings
• Translate data management metrics into clear visual reports for internal stakeholders
• Maintain and troubleshoot Power Query/Power BI data pipelines
• Ensure dashboard data accuracy through reconciliation against EDC source data
• Attend study-related meetings and teleconferences
• Track project progress and issue periodic status/metric reports
• Assist in identifying achievement of milestones per study timelines
• Participate in finalization and transfer of the clinical database and related documents to the sponsor
• Participate in internal meetings and internal/external audits as required
• Maintain awareness of contract scope and study-specific Clinical Data Management Plans

Requirements:

• Bachelor's degree in a health, science, or related discipline, or equivalent experience in clinical research
• Clinical data associate/management experience at a CRO, pharma, medical device, or biotech company
• Hands-on experience with EDC systems required (Castor EDC, Rave, Inform, or equivalent)
• Demonstrated proficiency managing reports/dashboards in Power BI
• Power Query/M language experience is a plus
• Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH)
• Proficiency with Microsoft Office (Excel, Word)
• Strong Excel skills required
• Experience working in cross-functional, multi-site clinical trial teams

Benefits:

• Great company culture
• Opportunities for professional growth
• Competitive wages
• Benefits