Job Description
Join MedTech Innovations as a Senior Clinical Research Manager and lead transformative healthcare initiatives in one of America's premier medical hubs. We're pioneering next-generation clinical trials for groundbreaking therapies, and we need your expertise to drive innovation from conception to regulatory approval.
Our Boston-based team operates at the intersection of biotechnology, digital health, and patient-centered care. You'll collaborate with world-class researchers, clinicians, and industry partners to develop protocols that set new standards in medical research.
Responsibilities
- Design and execute multi-phase clinical trial protocols adhering to FDA/ICH-GCP standards
- Lead cross-functional teams including biostatisticians, data managers, and regulatory affairs specialists
- Oversee site selection, recruitment strategies, and ethical compliance across 15+ research sites
- Analyze complex datasets using SAS/R to generate actionable insights for regulatory submissions
- Develop risk mitigation plans for clinical trial deviations and protocol amendments
- Present findings to FDA committees and international medical conferences
- Maintain $4M+ research budgets with 98% audit compliance
Qualifications
- PhD or PharmD with 8+ years of clinical research experience in therapeutic areas (Oncology/CNS preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record managing Phase II-III trials with 200+ subjects
- Expertise in electronic data capture systems (Medidata Rave) and clinical trial management software
- Strong statistical literacy with experience in survival analysis and Bayesian methods
- Experience leading FDA pre-IND meetings and post-marketing surveillance studies
- Prior publications in NEJM or Lancet with first-authorship on 3+ peer-reviewed papers