Job Description
Join our pioneering team at MediVance Solutions, where innovation meets compassion. We're seeking a visionary Senior Clinical Research Manager to lead groundbreaking studies that transform patient outcomes. In this pivotal role, you'll orchestrate complex clinical trials, ensuring regulatory compliance while driving therapeutic breakthroughs. Our collaborative environment offers cutting-edge resources and the opportunity to shape the future of healthcare.
MediVance Solutions combines rigorous scientific methodology with patient-centered care. You'll work alongside industry experts in our state-of-the-art Boston facility, contributing to trials that address critical unmet medical needs. We offer competitive compensation, comprehensive benefits, and continuous professional development in a culture that values intellectual curiosity and ethical integrity.
Responsibilities
- Design and execute multi-center clinical trials adhering to ICH-GCP and FDA regulations
- Lead cross-functional teams including physicians, biostatisticians, and regulatory affairs specialists
- Oversee protocol development, site selection, and patient recruitment strategies
- Analyze complex clinical data and prepare regulatory submissions (IND/IDE)
- Manage trial budgets exceeding $5M with meticulous financial oversight
- Maintain robust relationships with FDA, IRBs, and key opinion leaders
- Drive process improvements to enhance trial efficiency and patient safety
Qualifications
- PhD or PharmD in life sciences with 8+ years clinical research experience
- Proven track record managing Phase II-III therapeutic trials
- Expertise in oncology or rare disease therapeutics preferred
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and SAS programming
- Exceptional leadership skills with documented team development achievements
- Strong publication record in peer-reviewed medical journals
- Experience with global regulatory landscapes (EU, Japan, etc.)