Job Description
Join our pioneering team at Novartis, where we're reimagining medicine to improve and extend people's lives. We seek a dynamic Senior Clinical Research Associate to lead complex Phase II-III trials in our oncology division. You'll collaborate with cross-functional teams to ensure trial integrity, regulatory compliance, and patient safety while driving innovative clinical strategies.
Responsibilities
- Design and execute clinical trial protocols with FDA/EMA compliance
- Monitor investigational sites for protocol adherence and data integrity
- Lead site initiation, monitoring, and closure activities
- Analyze clinical data and prepare regulatory submissions
- Mentor junior CRAs and optimize trial workflows
- Manage vendor relationships and budget allocations
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years of clinical trial monitoring experience
- CRA certification (ACRP/SoCRA preferred)
- Therapeutic expertise in oncology or immunology
- Proficiency in EDC systems (e.g., Medidata Rave)
- Strong knowledge of ICH-GCP and regulatory requirements
- Exceptional problem-solving and communication skills