Job Description
Join Novartis Pharmaceuticals as a Senior Clinical Research Associate and drive innovation in life-changing therapies. We're seeking a passionate professional to oversee clinical trials, ensuring compliance with FDA regulations and GCP standards. This role offers the opportunity to work on cutting-edge oncology and immunology treatments while collaborating with global experts. Enjoy comprehensive benefits, professional development programs, and the chance to make a tangible impact on patients' lives.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials across multiple sites
- Ensure protocol adherence and regulatory compliance (FDA, EMA, ICH-GCP)
- Lead site initiation, monitoring, and closeout activities
- Analyze clinical data and prepare comprehensive study reports
- Maintain electronic trial master files and regulatory documentation
- Collaborate with cross-functional teams (medical, biostatistics, data management)
- Train and mentor junior CRAs on best practices
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (MS/PhD preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Deep knowledge of FDA 21 CFR Part 820 and ICH-GCP guidelines
- Experience with EDC systems (e.g., Medidata Rave, Oracle Inform)
- Strong data analysis and problem-solving skills
- Exceptional communication and stakeholder management abilities
- Ability to travel up to 40% of the time