Job Description
Shape the Future of Medicine at BioPharm Innovations
Join our dynamic team as a Senior Clinical Research Manager and lead pivotal trials that transform patient lives. We're pioneering next-generation therapies in oncology and rare diseases, and we need your expertise to navigate complex regulatory landscapes and accelerate drug development from preclinical to approval.
At BioPharm, we foster a culture of scientific excellence and collaboration. You'll work alongside industry leaders in our state-of-the-art Boston facility, leveraging cutting-edge technology to design innovative protocols and ensure data integrity. Your impact will directly influence the development of life-changing treatments.
Responsibilities
- Design and execute global clinical trial protocols with FDA/EMA compliance
- Lead cross-functional teams including CROs, investigators, and regulatory affairs
- Oversee site selection, monitoring, and vendor management
- Analyze complex clinical data and prepare regulatory submissions
- Develop risk-based monitoring strategies and ensure GCP adherence
- Mentor junior CRAs and implement process improvements
- Represent BioPharm at key scientific conferences and advisory boards
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field with 8+ years clinical research experience
- Proven track record of managing Phase II-III trials in oncology or rare diseases
- ICH-GCP/FDA regulations expertise and strong audit history
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Exceptional leadership and stakeholder management skills
- Advanced proficiency in eCRF systems and data management tools
- Demonstrated success in budget management and trial timelines
- Strong publication record in peer-reviewed journals