Job Description
Join Boston Medical Innovations at the forefront of clinical research excellence. We seek a Senior Clinical Research Manager to lead pivotal studies in oncology therapeutics. You'll drive protocol development, oversee multi-site trials, and ensure regulatory compliance while mentoring a dynamic research team. Our collaborative environment offers cutting-edge resources and opportunities to impact patient care globally.
Why Join Us? • Industry-leading benefits package • Dedicated research budget • Professional development stipend • Hybrid work model
Responsibilities
- Design and execute Phase I-III clinical trials in oncology
- Manage cross-functional teams (statisticians, data managers, investigators)
- Ensure FDA/ICH/GCP compliance across all trial activities
- Analyze complex datasets and prepare regulatory submissions
- Mentor junior research staff and optimize trial workflows
- Liaise with FDA, ethics committees, and international partners
Qualifications
- Master's degree in Clinical Research, Pharmacy, or related field
- 5+ years of oncology clinical trial management experience
- Certified Clinical Research Professional (CCRP) certification
- Proven success with FDA/EMA submissions
- Expertise in EDC systems (e.g., Medidata Rave)
- Strong leadership and cross-cultural communication skills
- Experience with CAR-T and immunotherapy trials preferred