Job Description
Join MedTech Innovations as a Senior Clinical Research Manager and lead groundbreaking medical trials that transform patient outcomes. We're seeking a visionary professional to oversee complex clinical studies from protocol design to regulatory submission. Our state-of-the-art Boston facility collaborates with top-tier medical institutions, offering unparalleled resources for impactful research. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of healthcare innovation.
Responsibilities
- Design and implement clinical trial protocols aligned with FDA/ICH guidelines
- Lead cross-functional teams of physicians, statisticians, and data specialists
- Ensure compliance with GCP standards and regulatory requirements
- Manage trial budgets exceeding $5M and vendor relationships
- Analyze complex data and prepare regulatory submissions (IND/IDE)
- Mentor junior researchers and develop department SOPs
- Present findings at medical conferences and peer-reviewed journals
Qualifications
- Master's or PhD in Life Sciences, Pharmacy, or related field
- 8+ years of clinical research experience with 3+ in leadership
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven track record in oncology/neurology trials preferred
- Expertise in EDC systems (Medidata Rave, Veeva Vault)
- Strong statistical analysis and SAS programming skills
- Exceptional project management with PMP certification
- Excellent written and verbal communication abilities