Senior Clinical Data Associate

Responsibilities

• Provide data management support throughout the clinical trial process from startup to post database lock
• Assist in developing CRF specifications and building clinical databases
• Conduct database build UAT and maintain quality controlled documentation
• Review and query clinical trial data according to the Data Management Plan
• Perform medical coding of medical terms to ensure logic and consistency
• Coordinate SAE/AE reconciliation and liaise with third-party vendors
• Run patient and study level status and metric reporting
• Train clinical research personnel on study specific CRF and EDC systems

Requirements

• 5+ years of experience in clinical data management or related field
• Bachelor's degree or equivalent related experience
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)
• Strong knowledge of ICH-GCP and regulatory guidance
• Excellent organizational and communication skills
• Professional fluency in English

Preferred Qualifications

• Experience in a clinical, scientific, or healthcare discipline
• Experience with dictionary medical coding (MedDRA and WHODrug)
• Understanding of CDISC standards (CDASH, SDTM, ADaM)
• Therapeutic experience in Oncology or Orphan Drugs

About the Company

Precision Medicine Group is an Equal Opportunity Employer dedicated to providing data management and clinical trial support services.