Clinical Data Associate

Requirements: • Associate's degree or higher• 2+ years of clinical data management experience within a biotech, pharmaceutical, or CRO environment• Hands-on experience with Electronic Data Capture (EDC) systems• Experience with Medidata Rave preferred• Strong organizational, communication, and problem-solving skills• Experience working in cross-functional clinical study teams Responsibilities• Support maintenance and updates of Data Management Plans, Data Validation Plans, Data Review Plans, and CRF Completion Guidelines• Review and verify external vendor data according to study specifications• Generate, review, and track study data metrics and reports• Participate in ongoing data review activities• Review, manage, and resolve data discrepancies within EDC systems• Perform external data reconciliations, including Serious Adverse Event (SAE) reconciliation• Conduct database quality control activities and support database review processes• Track data issues and communicate trends to study teams for follow-up• Ensure compliance with company procedures, GCP guidelines, and regulatory requirements• Maintain study documentation and support Trial Master File (TMF) activities Preferred• Experience with Medidata Rave• Experience supporting multiple clinical studies simultaneously• Strong understanding of GCP and clinical data management best practices Interviews are starting soon, so if you're interested and would like to be considered, give me a call at (919) 892-9841 as soon as you're available.