Job Description
Join MedTech Innovations Group at the forefront of medical breakthroughs as a Senior Clinical Research Manager. Lead transformative clinical trials that shape the future of patient care while collaborating with world-class physicians, scientists, and regulatory experts. Our Boston-based headquarters offers state-of-the-art facilities and a culture where innovation meets compassion. This pivotal role combines strategic oversight with hands-on leadership to ensure trial excellence from protocol design to FDA submission.
Responsibilities
- Design and execute multi-phase clinical trials across therapeutic areas
- Lead cross-functional teams including physicians, data scientists, and regulatory specialists
- Ensure GCP/ICH compliance and FDA regulatory submissions
- Oversee trial budgets exceeding $5M with financial stewardship
- Implement innovative ePRO systems and real-world data integration
- Present findings to FDA advisory panels and industry stakeholders
- Mentor junior research staff and develop department SOPs
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 8+ years clinical trial management with 3+ in leadership roles
- Proven track record with FDA submissions and audits
- Certification in Clinical Research Professional (CCRP) preferred
- Expertise in oncology or rare disease trials
- Advanced proficiency in CTMS and EDC platforms
- Experience with adaptive trial designs and AI-driven analytics
- Strong publication record in peer-reviewed medical journals