Job Description
Join Boston Medical Innovations as a Senior Clinical Research Manager and lead groundbreaking studies that transform patient outcomes. We're seeking a visionary professional to oversee complex clinical trials, ensuring compliance with FDA regulations while driving innovation in cardiovascular medicine. Our state-of-the-art research facility collaborates with Harvard Medical School and Massachusetts General Hospital, offering unparalleled resources to impact global healthcare.
As a key member of our R&D division, you'll mentor cross-functional teams, negotiate partnerships with leading pharmaceutical companies, and present findings at international conferences. We offer competitive benefits including malpractice coverage, 401(k) matching, and tuition reimbursement for advanced certifications.
Responsibilities
- Design and execute Phase I-III clinical trials for cardiovascular therapies
- Lead cross-functional teams of 15+ researchers, data analysts, and regulatory specialists
- Ensure 100% compliance with FDA, GCP, and ICH guidelines
- Manage $5M+ research budgets with quarterly financial reporting
- Develop strategic partnerships with NIH, FDA, and key opinion leaders
- Present findings at FDA advisory committees and peer-reviewed journals
- Implement electronic data capture systems and AI-driven analytics
Qualifications
- PhD or PharmD in Clinical Research, Pharmacology, or related field
- 8+ years of clinical trial management with 3+ in cardiovascular studies
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven track record of FDA submissions and audit readiness
- Expertise in EDC platforms (e.g., Medidata Rave) and statistical software
- Published research in peer-reviewed journals (minimum 5 publications)
- Strong leadership experience with matrixed teams
- Proficiency in ICH-GCP and 21 CFR Part 11 regulations