Job Description
Join our pioneering team at MediTech Innovations, where we're transforming healthcare through cutting-edge clinical research. As a Senior Clinical Research Manager, you'll lead pivotal studies that shape the future of patient care in our state-of-the-art Boston facility. We offer a collaborative environment where your expertise directly impacts medical breakthroughs while enjoying competitive compensation and comprehensive benefits.
Responsibilities
- Design and oversee multi-phase clinical trials ensuring compliance with FDA and GCP regulations
- Lead cross-functional teams including physicians, data scientists, and regulatory specialists
- Develop comprehensive study protocols and manage complex budgets exceeding $2M
- Analyze clinical data and prepare regulatory submissions for FDA approval
- Collaborate with pharmaceutical partners to accelerate therapeutic development
- Mentor junior researchers and implement quality improvement initiatives
Qualifications
- PhD or PharmD in Clinical Research, Life Sciences, or related field
- Minimum 7 years of clinical research management experience with Phase II-III trials
- Proven track record of FDA submissions and successful IND/NDAs
- Certification as a Principal Investigator (PI) or equivalent
- Expertise in oncology or rare disease therapeutic areas preferred
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and statistical software