Job Description
Join Boston Medical Innovations' cutting-edge oncology research division as we pioneer next-generation immunotherapies. We seek a Clinical Research Manager to oversee pivotal phase II/III trials in our state-of-the-art Longwood Medical Area facility. You'll lead cross-functional teams while maintaining compliance with FDA and ICH-GCP standards. Our collaborative environment offers competitive benefits, professional development grants, and opportunities to publish in leading medical journals.
Responsibilities
- Design and execute comprehensive clinical trial protocols for oncology therapeutics
- Manage budgets, timelines, and resource allocation for multi-center studies
- Oversee regulatory submissions and ensure compliance with 21 CFR Part 812
- Liaise with FDA, IRBs, and international ethics committees
- Lead data management strategy and statistical analysis planning
- Mentor junior research staff and conduct investigator training
- Collaborate with biostatisticians on protocol amendments and interim analyses
Qualifications
- Master's degree in Clinical Research, Pharmacy, or Life Sciences
- 5+ years of oncology clinical trial management experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in phase II/III oncology trial execution
- Deep knowledge of FDA regulations and EMA guidelines
- Experience with electronic data capture systems (e.g., Medidata Rave)
- Strong leadership skills with cross-functional team management
- Published research in peer-reviewed oncology journals preferred