Job Description
Join our pioneering team at MediCore Innovations, where cutting-edge healthcare meets transformative research. As a Senior Clinical Research Manager, you'll lead groundbreaking studies that shape the future of patient care in one of America's premier medical hubs. Our Boston-based facility offers state-of-the-art laboratories and collaborative partnerships with world-renowned institutions.
We're seeking a visionary leader to oversee multi-phase clinical trials, ensuring compliance with FDA regulations while driving innovation in therapeutic development. You'll mentor a dynamic team of research professionals and collaborate with pharmaceutical partners to bring life-changing treatments to market.
Responsibilities
- Design and execute comprehensive clinical trial protocols from Phase I to Phase III
- Manage cross-functional teams including data scientists, biostatisticians, and regulatory affairs specialists
- Ensure strict adherence to GCP standards and institutional review board protocols
- Oversee budget allocation and resource optimization for research initiatives
- Analyze complex clinical data and prepare regulatory submissions for FDA approval
- Collaborate with pharmaceutical partners to align research objectives with commercial goals
- Present findings to executive stakeholders and industry conferences
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- Minimum 8 years of clinical trial management experience in pharmaceutical or biotech setting
- Certification as a CRA (Certified Clinical Research Associate) or equivalent
- Proven track record of leading Phase II-III trials in therapeutic areas like oncology or immunology
- Expertise in regulatory compliance (FDA, EMA, ICH guidelines)
- Strong proficiency in EDC systems and clinical trial management software
- Exceptional leadership skills with experience managing remote research teams