Job Description
Join Novartis' innovative clinical development team as a Senior Clinical Research Associate and lead groundbreaking research that transforms patient lives. Based in our Boston hub, you'll orchestrate complex clinical trials, ensuring compliance with global regulatory standards while driving therapeutic breakthroughs. Collaborate with cross-functional experts to pioneer novel treatments across oncology, immunology, and rare diseases. This role offers unparalleled growth opportunities in a culture committed to scientific excellence and patient-centric innovation.
Responsibilities
- Design and execute Phase I-IV clinical trials adhering to ICH-GCP guidelines
- Monitor investigational sites for protocol compliance and data integrity
- Lead vendor management for CRO partnerships and clinical technology systems
- Develop risk-based monitoring strategies and site selection protocols
- Analyze clinical data and prepare regulatory submissions for FDA/EMA
- Mentor junior CRAs and optimize clinical trial processes
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with therapeutic area expertise
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated knowledge of FDA 21 CFR Part 820 and ISO 14155
- Exceptional problem-solving skills and regulatory navigation expertise
- Strong leadership experience with global cross-functional teams