Job Description
Join our pioneering team at Novartis Pharmaceuticals as a Senior Clinical Research Manager and lead groundbreaking clinical trials that transform patient lives. We're seeking a visionary leader to oversee complex Phase II-III studies in oncology, driving innovation from protocol design to regulatory submission. Collaborate with cross-functional experts across 5 global sites while ensuring compliance with ICH-GCP standards. Enjoy competitive benefits including flexible work arrangements and professional development stipends.
Responsibilities
- Design and execute global clinical trial strategies for oncology therapeutics
- Manage cross-functional teams of 15+ CRA, data managers, and biostatisticians
- Oversee $5M+ study budgets and vendor relationships
- Ensure regulatory compliance through FDA/EMA submissions and audits
- Present trial data to executive leadership and regulatory authorities
- Implement risk-based monitoring protocols to enhance data quality
Qualifications
- MS/PhD in Life Sciences or related field with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record leading oncology Phase II-III trials
- Expertise in eCRF design and CTMS systems (e.g., Medidata Rave)
- Strong knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional project management skills with PMP certification preferred