Job Description
Join our pioneering team at Novartis as a Senior Clinical Research Manager and lead transformative clinical trials that redefine global healthcare standards. Based in our Basel innovation hub, you'll orchestrate end-to-end trial execution, ensuring regulatory compliance and therapeutic breakthroughs. Collaborate with cross-functional experts in pharmacovigilance, biostatistics, and data management to accelerate life-changing therapies to market. We offer a dynamic environment where your expertise directly impacts patient outcomes and advances precision medicine.
Responsibilities
- Design and oversee global clinical trial protocols aligned with FDA/EMA regulations
- Manage cross-functional teams of 15+ CRA, data managers, and biostatisticians
- Monitor trial progress through risk-based monitoring strategies and site audits
- Lead safety signal detection and adverse event reporting processes
- Develop trial budgets exceeding CHF 5M and ensure financial stewardship
- Present trial results to FDA/EMA regulators and executive leadership
- Mentor junior CRMs and implement continuous improvement initiatives
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- ICH-GCP/ICH-E6(R2) certification and proven Phase II-III trial oversight
- Expertise in oncology or immunology therapeutic areas
- Fluency in English and German; French proficiency preferred
- Strong proficiency in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Experience managing global multi-center trials across 10+ countries
- Published peer-reviewed clinical trial data and regulatory submissions
- PMP certification or equivalent project management credentials