Job Description
Join MediGen Innovations, a leader in biopharmaceutical breakthroughs, as we pioneer next-generation therapies for cardiovascular diseases. We seek a dynamic Senior Clinical Research Manager to orchestrate groundbreaking clinical trials from concept to FDA submission. This pivotal role combines scientific rigor with operational excellence in Boston's premier medical innovation hub.
Why Join Us?
• Lead trials with global impact
• Collaborate with Nobel Prize-winning researchers
• Comprehensive benefits including equity and tuition reimbursement
• State-of-the-art facilities at Longwood Medical Area
Responsibilities
- Design and execute Phase I-III clinical trial protocols for novel cardiovascular therapies
- Manage cross-functional teams including biostatisticians, regulatory affairs, and data scientists
- Oversee site selection, monitoring, and compliance with FDA/ICH-GCP standards
- Analyze complex trial data and prepare regulatory submissions
- Present findings at international conferences and peer-reviewed journals
- Mentor junior research scientists and develop SOPs for clinical operations
- Collaborate with pharmaceutical partners on trial design and budgeting
Qualifications
- Master's degree in Life Sciences, Nursing, or related field (PhD preferred)
- 8+ years clinical research experience with 3+ in leadership roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record of managing 5+ complex cardiovascular trials
- Expertise in FDA 21 CFR Part 11 compliance and risk-based monitoring
- Strong proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Exceptional communication skills for stakeholder engagement
- Experience with adaptive trial designs and real-world evidence studies