Job Description
Join MedTech Innovations, a leader in pioneering medical device research, as we revolutionize patient care through cutting-edge clinical trials. We seek an experienced Senior Clinical Research Manager to oversee complex multi-center studies and drive regulatory compliance excellence. This role offers unparalleled opportunities to shape the future of healthcare innovation while collaborating with world-class physicians and biostatisticians.
Responsibilities
- Design and execute Phase I-III clinical trials for FDA-approved medical devices
- Manage cross-functional teams of CRAs, data managers, and biostatisticians
- Ensure GCP/ICH compliance and maintain regulatory documentation (IND/IDE)
- Analyze clinical data and prepare FDA submissions and safety reports
- Collaborate with KOLs to develop study protocols and endpoints
- Oversee site monitoring and audit processes across 15+ clinical sites
- Mentor junior research staff and implement process improvements
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field
- 8+ years of clinical research experience with medical devices
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven track record of leading FDA-compliant trials
- Expertise in electronic data capture systems (EDC) and RAVE
- Strong knowledge of 21 CFR Part 820 and ISO 13485 standards
- Experience managing multi-million dollar research budgets
- Exceptional problem-solving and stakeholder management skills