Job Description
Join our pioneering team at MediTech Innovations Inc., where we're revolutionizing patient outcomes through cutting-edge clinical research. As a Senior Clinical Research Manager, you'll lead high-impact studies in oncology and rare diseases, collaborating with world-class physicians and biotech partners. We offer a dynamic environment with state-of-the-art facilities, competitive benefits, and opportunities to publish groundbreaking findings. Your expertise will directly shape the future of precision medicine while mentoring the next generation of researchers.
Responsibilities
- Design and execute complex Phase II-III clinical trials with strict adherence to ICH-GCP and FDA regulations
- Lead cross-functional teams including biostatisticians, data managers, and regulatory affairs specialists
- Oversee site selection, investigator training, and protocol development across 15+ global sites
- Analyze safety data and prepare comprehensive regulatory submissions (INDs, NDAs)
- Present findings at international conferences and contribute to peer-reviewed publications
- Mentor junior CRAs and implement risk-based monitoring strategies
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field with 8+ years clinical research experience
- Proven track record in oncology or rare disease therapeutic areas
- ICH-GCP and FDA compliance expertise with audit experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and SAS/SPSS
- Strong leadership skills with demonstrated team management success
- Exceptional problem-solving abilities for protocol deviations and regulatory challenges