Job Description
Join BioVital Therapeutics at the forefront of pharmaceutical innovation. As a Senior Clinical Research Manager, you'll lead pivotal trials for breakthrough therapies in oncology and rare diseases. Drive life-changing research while mentoring a dynamic team in our state-of-the-art Cambridge facility. Enjoy competitive benefits, flexible work arrangements, and opportunities to contribute to groundbreaking treatments that impact global healthcare.
Responsibilities
- Design and execute global clinical trial protocols in compliance with FDA/ICH-GCP guidelines
- Lead cross-functional teams including CROs, investigators, and regulatory affairs specialists
- Oversee trial budgets exceeding $5M and ensure on-time milestone delivery
- Develop risk-based monitoring strategies and implement eClinical technologies
- Present trial data to senior leadership and regulatory authorities
- Mentor junior researchers and optimize clinical operations workflows
Qualifications
- MS/PhD in Life Sciences with 8+ years clinical research experience
- Proven track record managing Phase II-III oncology trials
- Expertise in FDA regulations and global clinical trial standards
- Strong proficiency in eClinical systems (Medidata Rave, Veeva Vault)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Exceptional problem-solving skills and stakeholder management expertise