Job Description
Join our pioneering team at Novartis Pharmaceuticals in Cambridge, MA, where innovation meets impact. As a Senior Clinical Research Associate, you'll drive the next generation of therapeutics through meticulous trial oversight and scientific leadership. We offer competitive compensation, cutting-edge resources, and a culture that values curiosity and collaboration.
Responsibilities
- Oversee clinical trial execution across multiple sites ensuring protocol compliance and GCP adherence
- Lead site monitoring visits, data verification, and regulatory documentation
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to optimize trial design
- Manage risk-based monitoring strategies and vendor relationships
- Contribute to SOP development and process improvement initiatives
- Mentor junior CRAs and train on emerging technologies
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in GCP environments
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in oncology or immunology therapeutic areas
- Strong knowledge of ICH-GCP, FDA, and EMA regulations
- Exceptional communication skills for stakeholder management
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring