Clinical Trial Manager
Company: Skills Alliance Agency
- Location: Massachusetts, United States
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
🫀 Clinical Trial Manager
Structural Heart Medtech | 📍 Massachusetts preferred, open to other US states for strong candidates | 🏠 Field-based, US
🚀 About the company
A growth-stage structural heart medical device company expanding its US presence. Join a small, fast-growing team with real ownership from day one.
🎯 The role
Lead day-to-day execution of US clinical studies as a key US-based Clinical Operations representative, working closely with investigators, research teams and cross-functional colleagues.
🔑 Key responsibilities
- 📋 Lead execution of US IDE and post-market clinical studies
- 🏥 Drive site activation, enrollment, monitoring, data quality and study milestones
- 🤝 Build strong relationships with investigators and research coordinators, with regular site visits (travel ~20% or less, sites near your location)
- 🧪 Oversee CROs, CRAs, core labs and other clinical vendors
- ⚠️ Support safety event, protocol deviation and product complaint follow-up
- 🎓 Support investigator meetings and clinical training
- ✅ Ensure compliance with protocols, GCP, ISO 14155 and FDA requirements
- 📣 Keep Clinical and Regulatory leadership updated
👤 What we’re looking for
- 🎓 Bachelor’s degree in life sciences, nursing, biomedical engineering or a related field
- 💼 5+ years of medical device clinical research experience, ideally at CTM or senior CRA level (strong CRAs ready to step up are welcome)
- 🇺🇸 US IDE study experience strongly preferred
- ❤️ Structural heart, interventional cardiology or cardiovascular device experience highly preferred
- 🩺 Strong site management and physician-facing skills
- ⚡ Independent, hands-on and organized, with a fast-paced mindset
- ✈️ Willingness to travel within the US
