Job Description
Join our award-winning medical research team at MediTech Innovations, where groundbreaking discoveries meet compassionate care. We're seeking a dynamic Senior Clinical Research Manager to lead pivotal trials in oncology therapeutics. You'll drive protocol development, oversee complex multi-center studies, and ensure compliance with FDA and ICH-GCP standards. Our state-of-the-art facility in Boston's Longwood Medical Area offers unparalleled resources and collaborative opportunities.
MediTech Innovations offers comprehensive benefits including health insurance, 401(k) matching, and continuing education stipends. Work alongside Nobel laureates and industry pioneers while advancing patient care through evidence-based research.
Responsibilities
- Design and implement comprehensive clinical trial protocols for oncology research
- Lead cross-functional teams including physicians, biostatisticians, and regulatory specialists
- Oversee site selection, initiation, and monitoring of multi-center trials
- Ensure strict adherence to regulatory requirements and ethical standards
- Analyze and interpret complex clinical data to support FDA submissions
- Mentor junior research staff and develop departmental SOPs
- Present findings at international conferences and peer-reviewed journals
Qualifications
- Master's degree in Life Sciences, Nursing, or related field (PhD preferred)
- 8+ years clinical research experience with 3+ in oncology trials
- Certified Clinical Research Professional (CCRP) certification required
- Proven track record in managing phase II-III oncology studies
- Expertise in FDA regulations, ICH-GCP, and EMA guidelines
- Strong statistical analysis skills using SAS or R
- Exceptional leadership and stakeholder management abilities