Clinical Trial Associate

Roles & Responsibilities:
• Manage and maintain Trial Master File (TMF / eTMF) ensuring 100% audit readiness
• Prepare and review Protocols, ICFs, CRFs, CSRs
• Ensure compliance with ICH-GCP, FDA 21 CFR Part 11, ISO 14155
• Coordinate Site Initiation, Monitoring, and Close-Out Visits
• Support regulatory submissions and health authority inspections
• Conduct internal audits and manage CAPA
• Work with CTMS & EDC systems (Medidata RAVE, Oracle Inform, Veeva Vault)
• Generate trial metrics and dashboards using Advanced Excel

Qualification:
• Bachelor’s degree in Life Sciences / Health Sciences / Nursing / Pharmacology
• GCP Certification (Mandatory)

Experience:
• 4–8 years in clinical research documentation & site coordination

Skills:
• Strong knowledge of TMF management, regulatory compliance, and clinical operations
• Proficiency in clinical trial systems and data management
• Excellent documentation, coordination, and analytical skills

About the Organization:
Hvantage is a growing clinical research and healthcare services organization, offering hybrid work flexibility, global trial exposure, and strong career growth opportunities for experienced professionals.