Job Description
Join our pioneering team at Boston Medical Innovations, where cutting-edge research meets compassionate care. We're seeking a visionary Senior Clinical Research Manager to lead transformative clinical trials that shape the future of medicine. In this pivotal role, you'll drive innovation in therapeutic development while ensuring the highest standards of patient safety and regulatory compliance.
Our state-of-the-art research facility in Boston's medical district offers unparalleled resources for advancing breakthrough treatments. You'll collaborate with world-class scientists, physicians, and regulatory experts to accelerate therapies from concept to commercialization. This is your opportunity to make a tangible impact on global healthcare outcomes while advancing your career in one of America's most vibrant medical communities.
Responsibilities
- Oversee end-to-end management of complex clinical trials, including protocol design, site selection, and regulatory submissions
- Lead cross-functional teams of research coordinators, data managers, and medical monitors to ensure trial integrity
- Ensure strict adherence to FDA regulations, ICH-GCP guidelines, and institutional review board protocols
- Analyze clinical trial data and prepare comprehensive reports for regulatory agencies and stakeholders
- Develop innovative strategies for patient recruitment and retention to meet enrollment targets
- Collaborate with biostatisticians to design robust clinical trial methodologies and statistical analysis plans
- Mentor junior research staff and establish best practices for clinical trial execution
Qualifications
- Master's degree in Clinical Research, Life Sciences, Pharmacy, or related field (PhD preferred)
- Minimum 7 years of clinical research experience with 3+ years in leadership roles
- Proven track record managing Phase II-III trials in therapeutic areas like oncology or immunology
- Deep expertise in FDA regulations, GCP, and clinical trial methodologies
- Certification as a Clinical Research Professional (CCRP) or equivalent
- Exceptional project management skills with experience in budget oversight
- Strong analytical abilities with proficiency in clinical trial management systems (e.g., Medidata Rave)