Job Description
Join MedCore Innovations, a leader in groundbreaking medical research, as we pioneer the next generation of therapeutics. We seek a passionate Senior Clinical Research Manager to lead pivotal clinical trials that directly impact patient lives. In this high-impact role, you'll oversee end-to-end trial execution, mentor cross-functional teams, and ensure compliance with FDA and ICH guidelines. Our collaborative environment offers unparalleled opportunities to shape regulatory strategies and accelerate drug development timelines.
Why MedCore? We're committed to fostering innovation through cutting-edge technology and a culture of scientific excellence. Our Boston campus features state-of-the-art labs and partnerships with top-tier medical institutions. Enjoy competitive benefits, flexible work arrangements, and opportunities to present findings at international conferences.
Responsibilities
- Design and execute Phase I-III clinical trials across therapeutic areas including oncology and neurology
- Lead cross-functional teams of 15+ CRAs, data managers, and biostatisticians
- Ensure 100% regulatory compliance through meticulous protocol development and site monitoring
- Collaborate with FDA and ethics committees to navigate complex regulatory pathways
- Analyze trial data and prepare comprehensive reports for executive stakeholders
- Mentor junior staff through targeted professional development programs
- Optimize trial budgets and timelines while maintaining quality standards
Qualifications
- Master’s or PhD in Life Sciences, Pharmacy, or related clinical field
- 8+ years of clinical research experience with 3+ years in leadership roles
- Certified CRA (ACRP) or equivalent professional certification required
- Proven track record of managing global multi-center trials (minimum 5 sites)
- Expertise in EDC systems (e.g., Medidata Rave) and regulatory documentation
- Strong knowledge of ICH-GCP, FDA 21 CFR Part 312, and EU Clinical Trial Regulation
- Exceptional problem-solving skills and ability to navigate ambiguous regulatory landscapes