Job Description
Join our pioneering team at MediCore Solutions, where innovation meets healthcare excellence. We're seeking a visionary Clinical Research Manager to lead groundbreaking clinical trials that shape the future of medicine. With cutting-edge facilities in Boston's renowned biomedical corridor, you'll drive protocol development, oversee site management, and ensure regulatory compliance while mentoring a dynamic research team. Enjoy competitive compensation, comprehensive benefits, and opportunities to present findings at global medical conferences.
Responsibilities
- Design, implement, and manage Phase I-IV clinical trials with strict adherence to FDA/ICH-GCP guidelines
- Lead cross-functional teams including data scientists, biostatisticians, and regulatory affairs specialists
- Oversee site selection, monitoring, and audit processes for 15+ clinical sites nationwide
- Develop comprehensive trial budgets and ensure financial compliance with sponsors
- Prepare FDA submissions and maintain real-time trial documentation in electronic systems
- Present trial outcomes to executive stakeholders and regulatory bodies
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 7+ years clinical research experience with 3+ years in leadership roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record in managing complex oncology or rare disease trials
- Expertise in electronic data capture systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of 21 CFR Part 11, HIPAA, and international regulatory standards