Job Description
Join Novartis' cutting-edge Clinical Development team where innovation meets patient impact. As a Senior Clinical Research Manager, you'll lead pivotal global trials for breakthrough therapies in oncology and immunology. Collaborate with cross-functional experts to design protocols, ensure regulatory compliance, and accelerate life-changing treatments to market. Our state-of-the-art Princeton campus offers unparalleled resources and a culture that champions scientific excellence and professional growth.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to final report
- Manage CRO partnerships and vendor performance metrics
- Ensure adherence to ICH-GCP, FDA regulations, and company SOPs
- Lead cross-functional teams including biostatisticians, data managers, and medical writers
- Develop risk-based monitoring strategies and quality management plans
- Represent clinical development at regulatory authority interactions
- Mentor junior CRMs and contribute to process improvements
Qualifications
- MS/PhD in Life Sciences or PharmD with 8+ years clinical research experience
- Proven track record leading Phase II-III oncology/immunology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA/EMA regulatory requirements and GCP compliance
- Strong project management skills with PMP certification preferred
- Exceptional leadership and cross-functional collaboration abilities
- Experience with ePRO/eCRF systems and risk-based monitoring