Job Description
Join our pioneering team at MediSolutions Group, where innovation meets impact. As a Senior Clinical Research Manager, you'll lead transformative clinical trials that shape the future of healthcare. We offer a collaborative environment, cutting-edge resources, and the opportunity to work on breakthrough therapies. Our Boston-based headquarters is a hub of medical excellence, combining rigorous science with compassionate patient care. If you're passionate about accelerating medical discoveries and improving lives, this is your moment to shine.
Responsibilities
- Design and execute Phase I-IV clinical trials with precision and regulatory compliance
- Lead cross-functional teams of 15+ professionals across biostatistics, data management, and regulatory affairs
- Oversee trial budgets exceeding $5M and ensure financial accountability
- Develop comprehensive trial protocols and ensure FDA/ICH-GCP adherence
- Present findings to FDA panels and key stakeholders at major medical conferences
- Mentor junior researchers and foster a culture of scientific excellence
Qualifications
- PhD or PharmD in Clinical Research, Life Sciences, or related field
- 8+ years of progressive clinical trial management experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record with FDA submissions and regulatory inspections
- Expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in clinical trial management software (e.g., Veeva Vault)
- Strong publication record in peer-reviewed medical journals