Job Description
Join MedTech Innovations as a Clinical Research Manager and lead groundbreaking medical studies that shape the future of healthcare. We're seeking a visionary leader to oversee clinical trials from protocol design to regulatory submission, ensuring compliance with FDA/ICH-GCP standards. Collaborate with cross-functional teams in our state-of-the-art Boston facility to accelerate life-changing therapies to market.
What We Offer:
- Comprehensive benefits package including health/dental/vision
- 401(k) with 6% employer match
- Professional development stipend
- Flexible hybrid work arrangement
- Cutting-edge research resources
Responsibilities
- Design, implement, and manage complex clinical trial protocols
- Lead cross-functional teams (MDs, biostatisticians, data managers)
- Ensure regulatory compliance (FDA, EMA, ICH-GCP)
- Monitor trial progress and resolve protocol deviations
- Prepare FDA/EMA submissions and safety reports
- Collaborate with CROs and investigative sites globally
- Analyze clinical data and prepare study reports
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years clinical research with 2+ years in management
- Certified Clinical Research Professional (CCRP) required
- Proven experience with oncology/neurology trials preferred
- Deep knowledge of FDA 21 CFR Part 11 compliance
- Strong project management (PMP certification a plus)
- Exceptional problem-solving and communication skills