Job Description
Join MedTech Innovations, a leader in digital health solutions, as we revolutionize patient care through AI-driven clinical trials. We're seeking a visionary Senior Clinical Research Manager to spearhead pivotal studies in our Boston R&D hub. Lead cross-functional teams in designing and executing cutting-edge protocols while ensuring regulatory compliance and data integrity. This role offers unparalleled opportunities to shape the future of evidence-based medicine with competitive benefits and career growth.
Responsibilities
- Design, implement, and oversee complex clinical trial protocols in compliance with FDA/ICH-GCP standards
- Lead cross-functional teams including biostatisticians, data managers, and medical writers
- Ensure regulatory compliance and ethical approval processes for multi-center studies
- Analyze complex clinical datasets to generate actionable insights for product development
- Collaborate with regulatory affairs to prepare submissions for FDA/EMA approvals
- Mentor junior researchers and optimize clinical trial methodologies
- Present findings to executive stakeholders and scientific conferences
Qualifications
- PhD or MD/DO with 5+ years in clinical research management
- Proven expertise in oncology or cardiology therapeutic areas
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Strong proficiency in clinical trial management systems (e.g., Medidata Rave)
- Experience with FDA/EMA regulatory submissions and audits
- Demonstrated leadership in managing multi-center trials (≥3 sites)
- Advanced statistical analysis skills (SAS/R programming)
- Published peer-reviewed research in high-impact journals