Job Description
Join our pioneering team at Boston Medical Innovations where we're revolutionizing patient care through cutting-edge clinical trials. We seek a dynamic Senior Clinical Research Manager to lead multi-center oncology studies, ensuring regulatory compliance and data integrity while mentoring junior staff. Enjoy competitive benefits, flexible work arrangements, and opportunities to present findings at international conferences. Our state-of-the-art facility in Boston's Longwood Medical Area offers unparalleled resources for impactful research.
Responsibilities
- Design and execute complex Phase II-III oncology clinical trials across 10+ sites
- Ensure FDA/ICH/GCP compliance and maintain rigorous audit readiness
- Lead cross-functional teams of 15+ CRAs, data managers, and biostatisticians
- Develop comprehensive study protocols and regulatory submission packages
- Analyze safety data and prepare reports for FDA/IRB submissions
- Manage $2M+ annual budgets with precise financial oversight
- Present findings at SITC, ASCO, and ESMO conferences
Qualifications
- MS/PhD in life sciences or related field with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record leading oncology trials with 5+ IND/IDE submissions
- Expertise in EDC systems (Medidata Rave) and risk-based monitoring
- Strong FDA audit experience with zero critical findings in last 3 audits
- Exceptional leadership skills managing remote teams across time zones
- Published in peer-reviewed journals (minimum 3 first-author papers)