Job Description
Join our pioneering team at MedTech Innovations, where we're revolutionizing patient care through cutting-edge medical research. We seek a dynamic Senior Clinical Research Manager to lead multi-phase clinical trials for our groundbreaking therapies in oncology and immunology. This role offers unparalleled opportunity to shape the future of medicine while collaborating with world-class physicians and scientists in our state-of-the-art Boston facility.
Responsibilities
- Design and execute comprehensive clinical trial protocols adhering to FDA/ICH-GCP standards
- Lead cross-functional teams including physicians, statisticians, and regulatory experts
- Oversee site management, vendor relationships, and budget allocation for $5M+ studies
- Ensure data integrity through rigorous CRF review and audit compliance
- Present findings at regulatory submissions and international medical conferences
- Mentor junior staff and optimize clinical trial methodologies
Qualifications
- PhD/MD or Master's in Life Sciences with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record managing Phase I-III oncology trials
- Expertise in EDC systems (e.g., Medidata Rave) and regulatory documentation
- Strong statistical analysis and risk management capabilities
- Exceptional leadership skills with experience managing 10+ person teams