Job Description
Join MedTech Innovations, a leader in cutting-edge medical research, as we revolutionize patient care through groundbreaking clinical trials. Our Boston-based team is seeking a visionary Senior Clinical Research Manager to oversee pivotal studies in oncology and immunotherapy. You'll drive innovation while ensuring regulatory compliance and data integrity in a collaborative, state-of-the-art environment.
Responsibilities
- Lead end-to-end management of Phase I-III clinical trials, from protocol design to final report submission
- Coordinate cross-functional teams including medical monitors, biostatisticians, and regulatory affairs specialists
- Ensure adherence to FDA regulations, ICH-GCP guidelines, and ethical research standards
- Develop and maintain trial budgets, timelines, and resource allocation plans
- Oversee site selection, monitoring, and vendor management for multi-center studies
- Present trial outcomes to executive leadership and regulatory authorities
- Mentor junior research staff and implement process improvements
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- Minimum 7 years clinical research experience with 3+ years in leadership roles
- Proven track record managing complex oncology/immunotherapy trials
- Expertise in FDA regulations, EMA guidelines, and GCP compliance
- Advanced proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Strong strategic planning and stakeholder management abilities