Job Description
Join Novartis Pharmaceuticals at our Cambridge innovation hub, where breakthroughs in biotechnology and pharmaceuticals converge. As a Senior Clinical Research Associate, you'll drive pivotal clinical trials that transform patient outcomes. Our state-of-the-art facilities and collaborative culture empower you to lead complex studies while ensuring regulatory excellence. This role offers unparalleled opportunities to shape the future of medicine in one of the world's leading biotech clusters.
Responsibilities
- Design and execute Phase I-III clinical trials adhering to GCP/ICH guidelines
- Lead site monitoring activities with 80% travel to global investigational sites
- Manage clinical documentation and regulatory submissions (IND/IMPD)
- Collaborate with cross-functional teams (medical, data, biostatistics)
- Analyze safety data and prepare pharmacovigilance reports
- Mentor junior CRAs and optimize trial workflows
Qualifications
- Master's degree in life sciences/pharmacy or equivalent experience
- 5+ years clinical research with Phase II-III trial exposure
- Certified CRA (ACRP/SoCRA) required
- Proven expertise in EDC systems (Medidata Rave preferred)
- Strong knowledge of FDA/EMA regulations
- Exceptional data management and audit skills
- Fluency in English and additional language beneficial