Job Description
Join NovoBio Therapeutics at the forefront of pharmaceutical innovation. We're seeking a visionary Senior Clinical Research Manager to lead groundbreaking trials that transform patient outcomes. In this pivotal role, you'll orchestrate complex studies while mentoring cross-functional teams across our Cambridge headquarters. Enjoy competitive benefits, cutting-edge resources, and the opportunity to shape the future of medicine.
Responsibilities
- Design and execute Phase I-III clinical trials adhering to ICH-GCP and FDA regulations
- Lead cross-functional teams including clinicians, biostatisticians, and regulatory affairs specialists
- Oversee clinical site selection, monitoring, and vendor management
- Develop comprehensive clinical trial protocols and study budgets
- Analyze complex data to ensure trial integrity and regulatory compliance
- Mentor junior staff and implement continuous process improvements
- Represent clinical operations in internal and external stakeholder meetings
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field with 8+ years clinical research experience
- Proven track record managing Phase II-III trials in therapeutic areas (Oncology/CNS preferred)
- Deep expertise in FDA regulations, ICH-GCP, and clinical trial methodologies
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Exceptional leadership skills with experience managing cross-functional teams
- Strong data interpretation and risk management capabilities
- Proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Excellent communication skills with ability to present to senior leadership