Job Description
Join MedTech Innovations Inc., a leader in cutting-edge medical device development, as we revolutionize patient care through innovative clinical trials. We're seeking a passionate Clinical Research Manager to oversee pivotal studies and drive breakthroughs in cardiovascular treatments. This role offers hybrid flexibility in Boston's thriving biotech corridor, with competitive benefits and opportunities to shape the future of medicine.
Our ideal candidate thrives in fast-paced environments and values precision, collaboration, and scientific excellence. You'll work alongside top-tier researchers, regulatory experts, and healthcare professionals to ensure trials meet FDA standards while accelerating time-to-market for life-changing technologies.
Responsibilities
- Design, implement, and monitor Phase II-III clinical trials for novel cardiac monitoring devices
- Lead cross-functional teams including data managers, biostatisticians, and clinical coordinators
- Ensure compliance with ICH-GCP, FDA regulations, and institutional review board protocols
- Analyze trial data and prepare comprehensive reports for regulatory submissions
- Manage vendor relationships and oversee trial budgets exceeding $2M
- Mentor junior staff and develop innovative clinical research methodologies
- Present findings at industry conferences and peer-reviewed publications
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical trial management experience in medical device sector
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record with FDA submissions and audit readiness
- Expertise in cardiac/vascular therapeutic areas
- Advanced proficiency in eCRF systems and clinical trial management software
- Strong statistical analysis skills using SAS or R
- Exceptional communication and stakeholder management abilities