Job Description
Join our pioneering team at MedTech Innovations, a leader in transformative medical research. We're seeking a Senior Clinical Research Manager to drive groundbreaking studies in cardiovascular therapies at our Boston headquarters. This role offers the opportunity to shape the future of patient care while collaborating with world-class physicians and scientists in a state-of-the-art facility.
As a key member of our Research & Development division, you'll oversee end-to-end clinical trial management from protocol design to regulatory submission. We provide comprehensive benefits including health insurance, 401(k) matching, and professional development stipends. Our culture emphasizes innovation, integrity, and patient-centered outcomes.
Responsibilities
- Design and execute multi-phase clinical trials adhering to FDA/ICH-GCP standards
- Lead cross-functional teams of physicians, data scientists, and regulatory specialists
- Manage trial budgets exceeding $2M and ensure timely milestone achievement
- Analyze complex biomedical data and prepare regulatory submissions (INDs/NDAs)
- Collaborate with FDA and international regulatory bodies during audits
- Mentor junior researchers and develop department SOPs
- Present findings at medical conferences and peer-reviewed journals
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record managing phase II-III cardiovascular trials
- Expertise in FDA regulations, EMA guidelines, and global compliance frameworks
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and statistical analysis tools
- Exceptional leadership skills with ability to manage remote international teams
- Strong publication record in peer-reviewed medical journals
- Experience with rare disease trial protocols preferred