Job Description
Join MedTech Innovations as a Clinical Research Manager to lead groundbreaking medical studies at the intersection of biotechnology and patient care. You'll oversee complex clinical trials, collaborate with multidisciplinary teams, and drive innovations that transform healthcare outcomes. Our Boston-based facility offers cutting-edge resources and a culture dedicated to scientific excellence.
Responsibilities
- Design and execute Phase I-III clinical trials adhering to FDA regulations and GCP standards
- Lead cross-functional teams including physicians, data scientists, and regulatory specialists
- Manage trial budgets exceeding $2M and ensure protocol compliance
- Analyze complex biomedical data and prepare regulatory submissions
- Develop strategic partnerships with academic medical centers and biotech firms
- Mentor junior researchers and ensure team compliance with IRB protocols
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- 5+ years managing clinical trials with therapeutic device experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record in FDA/EMA submissions and audit readiness
- Expertise in electronic data capture systems (e.g., Medidata Rave)
- Strong statistical analysis skills using SAS or R
- Exceptional communication skills for stakeholder management