Job Description
Shape the future of healthcare by leading groundbreaking clinical trials at BioPharm Innovations. As a Senior Clinical Research Manager, you'll drive the development of life-changing therapies while ensuring regulatory compliance and scientific excellence. Join our award-winning team in Boston's premier biotech hub where innovation meets impact.
We offer competitive compensation, comprehensive benefits, and unparalleled opportunities for professional growth. Your expertise will directly influence the trajectory of novel treatments that benefit patients worldwide.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to final report submission
- Lead cross-functional teams including CRAs, medical monitors, and data managers
- Ensure compliance with FDA regulations, GCP standards, and ICH guidelines
- Manage clinical trial budgets and vendor relationships
- Develop risk-based monitoring strategies and quality management systems
- Represent the company in interactions with regulatory authorities and ethics committees
- Mentor junior staff and contribute to departmental process improvements
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 8+ years of clinical research experience with 3+ years in management
- Proven track record of leading Phase II-III clinical trials in therapeutic areas
- Expert knowledge of FDA regulations, GCP, and ICH guidelines
- Strong project management skills with PMP certification or equivalent
- Exceptional leadership and cross-functional collaboration abilities
- Experience with EDC systems and risk-based monitoring methodologies
- Excellent written and verbal communication skills