Job Description
Join BioMed Innovations Institute, a leader in cutting-edge medical research, as we pioneer breakthrough therapies in oncology and immunology. We're seeking a dynamic Senior Clinical Research Manager to oversee pivotal clinical trials from protocol design to FDA submission. Enjoy competitive compensation, comprehensive benefits, and a collaborative environment where your expertise directly impacts patient outcomes.
Responsibilities
- Lead multidisciplinary teams in executing Phase I-III clinical trials
- Ensure compliance with ICH-GCP, FDA regulations, and institutional protocols
- Manage clinical trial budgets exceeding $5M with precise financial oversight
- Develop innovative trial methodologies to enhance patient recruitment
- Coordinate with CROs, investigators, and regulatory authorities
- Analyze complex clinical data and prepare regulatory submissions
- Mentor junior staff and implement continuous process improvements
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field
- 8+ years of clinical trial management experience in biotech/pharma
- Proven track record with FDA submissions and inspections
- Certified Clinical Research Professional (CCRP) or equivalent
- Expertise in oncology/immunology therapeutic areas
- Advanced proficiency in EDC systems (e.g., Medidata Rave)
- Exceptional leadership and cross-functional collaboration skills
- Strong analytical abilities with experience in risk-based monitoring