Job Description
Join MedTech Innovations as a Clinical Research Manager and lead transformative clinical trials that shape the future of medicine. We're seeking a visionary professional to drive our cutting-edge research initiatives in cardiovascular devices at our Boston headquarters. You'll collaborate with top-tier medical professionals, regulatory experts, and biostatisticians to ensure compliance with FDA/ICH guidelines while accelerating time-to-market for life-changing therapies. This role offers unparalleled growth opportunities in one of America's premier healthcare innovation hubs.
Responsibilities
- Design and execute clinical trial protocols in alignment with FDA regulations and ICH-GCP standards
- Lead cross-functional teams including physicians, nurses, and data coordinators
- Manage trial budgets exceeding $2M with rigorous financial oversight
- Oversee site selection, investigator relationships, and ethical compliance
- Analyze complex clinical data and prepare regulatory submissions
- Implement risk-based monitoring strategies to ensure data integrity
- Maintain real-time trial documentation in EDC systems
- Present trial outcomes to executive stakeholders and regulatory bodies
Qualifications
- Master's degree in Life Sciences, Nursing, or Clinical Research (PhD preferred)
- 5+ years clinical trial management experience in medical device/pharma
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA 21 CFR Part 820 and ISO 13485 compliance
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Strong statistical analysis skills with SAS or R experience
- Exceptional project management with PMP certification
- Demonstrated success in managing multicenter international trials