Job Description
Join Novartis at the forefront of pharmaceutical innovation as a Senior Clinical Research Manager. Lead pivotal global clinical trials, drive therapeutic breakthroughs in oncology and immunology, and shape the future of patient care. Collaborate with cross-functional teams to ensure regulatory compliance and data integrity while mentoring junior researchers. This role offers unparalleled opportunities to impact global health outcomes in a dynamic, science-driven environment.
Responsibilities
- Design and execute global Phase II-III clinical trial protocols in oncology/immunology
- Lead cross-functional teams (CRA, biostatisticians, medical monitors) to ensure trial milestones
- Oversee site selection, investigator relationships, and vendor management
- Analyze clinical data and prepare regulatory submissions (FDA, EMA, PMDA)
- Develop risk-based monitoring strategies and ensure GCP compliance
- Mentor junior CRMs and contribute to process improvements
- Present trial results to internal stakeholders and external partners
Qualifications
- PhD or PharmD in life sciences with 5+ years clinical research experience
- Proven track record managing global Phase II-III oncology trials
- ICH-GCP/21 CFR Part 312 expertise and regulatory submission experience
- Advanced proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Strong leadership skills with cross-functional team management
- Fluency in English and German; French beneficial
- Therapeutic area expertise in immuno-oncology preferred