Tech Stack

Description

As our Clinical Data Manager, you will perform hands-on data management activities across clinical studies, from start-up through database lock. You'll oversee data collection, cleaning, and review to ensure accuracy and regulatory readiness, collaborating with Clinical Operations, Biostatistics, and external vendors.

Requirements

• Bachelor's degree in health science, life science, mathematics, or related field
• 3-6+ years of hands-on clinical data management experience in medical device, biotech, or pharmaceutical
• Experience with EDC system (Veeva EDC preferred)
• Working knowledge of GCP, ICH guidelines, and 21 CFR Part 11
• Strong analytical and problem-solving skills

Responsibilities

• Interpret study protocols to support eCRF design and development
• Create and review edit checks for data capture and validation
• Review EDC builds and participate in user acceptance testing
• Support production release readiness and assess study change impacts
• Assess protocol amendments and support database updates