Job Description
Join Novartis' global oncology division to pioneer breakthrough therapies for cancer patients. As a Senior Clinical Research Manager, you'll lead complex international clinical trials from Phase I to III, ensuring regulatory compliance and data integrity. Collaborate with cross-functional teams to accelerate drug development timelines while maintaining the highest ethical standards. This role offers unparalleled opportunities to impact patient outcomes through innovative clinical research methodologies.
Responsibilities
- Design and execute global clinical trial protocols in oncology therapeutics
- Lead cross-functional teams including CRAs, biostatisticians, and medical monitors
- Ensure compliance with ICH-GCP, FDA, and EMA regulations
- Manage trial budgets and vendor relationships across 15+ countries
- Analyze clinical data and prepare regulatory submissions
- Mentor junior staff and implement process improvements
- Present trial outcomes at international scientific conferences
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- Proven track record managing Phase I-III oncology trials
- ICH-GCP certification and strong regulatory affairs knowledge
- Expertise in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Exceptional leadership and cross-cultural communication skills
- Experience with FDA/EMA interactions and protocol amendments
- Strong publication record in peer-reviewed oncology journals