Job Description
Join Global Health Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments for tomorrow's healthcare challenges. We seek a Clinical Research Manager to orchestrate pivotal clinical trials in our state-of-the-art Boston facility. Lead multidisciplinary teams while ensuring regulatory compliance and accelerating life-changing therapies to market.
Collaborate with industry pioneers in a dynamic environment where innovation meets patient impact. Enjoy comprehensive benefits including professional development stipends and flexible work arrangements.
Responsibilities
- Design and implement comprehensive clinical trial protocols adhering to FDA/ICH-GCP standards
- Lead cross-functional teams of physicians, data scientists, and regulatory specialists
- Oversee site selection, vendor management, and budget allocation for multi-center trials
- Ensure real-time compliance with regulatory requirements and ethical guidelines
- Analyze complex trial data and prepare regulatory submissions for FDA approval
- Present findings to stakeholders and contribute to publication in peer-reviewed journals
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical trial management experience with Phase II-III trials
- Certification as a Certified Clinical Research Professional (CCRP) or equivalent
- Proven expertise in FDA/ICH-GCP compliance and regulatory documentation
- Strong proficiency in electronic data capture systems (e.g., Medidata Rave)
- Exceptional leadership skills with experience managing 10+ person teams
- Demonstrated success in publishing trial outcomes in high-impact journals