Job Description
Join MediCore Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough therapies for rare diseases. We seek a dynamic Senior Clinical Research Manager to lead pivotal clinical trials in our Boston-based facility. This role offers unparalleled opportunities to shape the future of healthcare while collaborating with world-class scientists and regulatory experts. Our commitment to innovation is matched only by our dedication to patient-centered outcomes.
As part of our elite research team, you'll drive the end-to-end execution of complex clinical trials, ensuring compliance with FDA regulations and GCP standards. We offer a collaborative, growth-oriented environment with competitive benefits, including professional development stipends and flexible work arrangements. Help us transform medical science into life-changing treatments.
Responsibilities
- Lead design, implementation, and monitoring of Phase II-III clinical trials across multiple therapeutic areas
- Oversee cross-functional teams of CRA's, data managers, and biostatisticians
- Ensure protocol adherence and regulatory compliance (FDA, EMA, ICH-GCP)
- Develop comprehensive trial budgets and resource allocation plans
- Manage investigator relationships and site selection/activation
- Prepare and submit regulatory documentation and ethics committee submissions
- Analyze trial data and prepare clinical study reports for FDA submissions
Qualifications
- Master's degree in Life Sciences, Nursing, or related field (PhD preferred)
- 8+ years clinical research experience with 3+ in leadership roles
- Proven track record managing Phase II-III trials in rare diseases
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Deep knowledge of FDA regulations and ICH-GCP guidelines
- Exceptional project management and risk mitigation skills
- Strong proficiency in eCRF systems and clinical trial management software
- Excellent written and verbal communication skills for stakeholder reporting