Job Description
Join NovoMed Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer groundbreaking therapies for rare diseases. We seek a Senior Clinical Research Manager to lead complex clinical trials from protocol design to FDA submission. This role offers the opportunity to shape regulatory strategies and collaborate with cross-functional teams to accelerate life-changing treatments to market.
Why Join Us? At NovoMed, you'll work in state-of-the-art facilities with cutting-edge technology. Our culture emphasizes scientific excellence, collaboration, and career development through continuous learning and mentorship programs. We offer comprehensive benefits including equity participation and flexible work arrangements.
Responsibilities
- Design, implement, and oversee Phase I-III clinical trials adhering to ICH-GCP and FDA regulations
- Lead cross-functional teams including CRAs, biostatisticians, and medical writers
- Develop clinical trial protocols, case report forms, and study budgets
- Manage vendor relationships and CRO partnerships for trial execution
- Analyze clinical data and prepare regulatory submissions (IND, NDA)
- Mentor junior staff and contribute to process improvements in clinical operations
Qualifications
- MS/PhD in Life Sciences or related field with 8+ years clinical research experience
- Proven track record leading global Phase II-III trials in rare disease or oncology
- Strong expertise in FDA/EMA regulatory requirements and risk-based monitoring
- Certified Clinical Research Professional (CCRP) or equivalent preferred
- Experience with EDC systems (e.g., Medidata Rave) and ePRO solutions
- Demonstrated success in managing complex budgets and timelines
- Exceptional problem-solving and communication skills