Job Description
Join NovoMed Therapeutics as a Senior Clinical Research Associate and drive groundbreaking advancements in pharmaceutical innovation. We're seeking a passionate professional to lead clinical trial execution across multiple therapeutic areas. This role offers unparalleled opportunities to shape the future of medicine while working in a collaborative, cutting-edge environment. Enjoy competitive compensation, comprehensive benefits, and career growth in Boston's thriving biotech hub.
Responsibilities
- Oversee clinical trial operations including site monitoring, protocol compliance, and vendor management
- Lead cross-functional teams to ensure trial milestones are met within regulatory guidelines
- Analyze complex clinical data and prepare regulatory submissions for FDA/EMA approval
- Develop and maintain strong relationships with investigative sites and key opinion leaders
- Implement risk-based monitoring strategies to optimize trial efficiency and data integrity
- Mentor junior associates and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Deep expertise in ICH-GCP, FDA/EMA regulations, and SOPs
- Proven track record in managing complex multi-center trials
- Strong data management and statistical analysis skills
- Exceptional communication and stakeholder management abilities