Job Description
Join BioVance Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies for rare diseases. We seek a passionate Senior Clinical Research Associate to drive our Phase II-III clinical trials from concept to FDA approval. In this pivotal role, you'll collaborate with cross-functional teams to ensure protocol integrity, regulatory compliance, and patient safety while advancing breakthrough treatments that transform global healthcare.
Responsibilities
- Design and execute clinical trial protocols adhering to ICH-GCP and FDA regulations
- Lead site monitoring visits, audits, and vendor management to ensure data integrity
- Oversee regulatory submissions, including IND/BLA documentation and safety reporting
- Analyze clinical data and prepare comprehensive study reports for stakeholders
- Mentor junior associates and optimize clinical trial processes
- Collaborate with biostatisticians on endpoint validation and statistical analysis plans
- Manage investigational product supply chain and ethical review board communications
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research with 5+ years' experience
- CCRA certification or equivalent regulatory affairs certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated success in managing multi-center global trials
- Exceptional problem-solving skills for complex protocol deviations
- Fluency in regulatory requirements across EU/US/Asia markets
- Strong leadership abilities with cross-functional team management experience