Job Description
Join BioPharm Innovations Inc., a leading biopharmaceutical pioneer transforming global healthcare through groundbreaking therapies. We seek a passionate Senior Clinical Research Associate to drive our next-generation clinical trials from Boston's innovation hub. Lead critical studies in oncology and immunotherapy while collaborating with world-class scientists to accelerate life-changing treatments.
Why BioPharm? • Cutting-edge research facilities • Industry-leading compensation package • Comprehensive professional development • Collaborative, mission-driven culture • Opportunity to impact patient lives globally.
Responsibilities
- Design and execute complex clinical trial protocols adhering to FDA/ICH-GCP regulations
- Monitor trial sites globally ensuring data integrity and regulatory compliance
- Lead cross-functional teams including medical, regulatory, and data science experts
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approvals
- Mentor junior CRAs and optimize clinical trial methodologies
- Represent company at international scientific conferences and investigator meetings
Qualifications
- Master's degree in Life Sciences/Pharmacy or equivalent with 5+ years clinical research experience
- Proven expertise in oncology and immunotherapy trial management
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Deep knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional data interpretation and risk management skills
- Strong proficiency in electronic data capture systems (e.g., Medidata Rave)
- Experience managing global multi-center trials (Phase I-III)