Job description
Join Aurora Specialty Health as a Clinical Research Scientist focused on Specialized Medicine. Based in Boston, you will lead early- to late-phase studies in neurology, oncology, or rare diseases, ensuring regulatory compliance and data integrity.
We offer a dynamic environment, hybrid work options, competitive compensation, and a path to leadership in a growing organization dedicated to breakthrough therapies.
Responsibility
- Lead study design, protocol development, and statistical analysis plans for specialized medicine trials.
- Oversee trial operations, site coordination, vendor management, and compliance with study milestones.
- Ensure GCP, ICH guidelines, IRB/IEC submissions, and regulatory documentation.
- Develop and monitor data quality plans, monitoring schedules, and data safety reporting.
- Collaborate with biostatistics, safety, medical writing, and regulatory affairs teams to drive study success.
- Mentor junior researchers and support publications, abstracts, and congress presentations.
- Maintain patient safety focus and proactively manage risk throughout the trial lifecycle.
Qualification
- MD, DO, PhD in life sciences, or PharmD with at least 5 years of clinical research experience in specialized medicine.
- Strong knowledge of GCP, ICH, IRB/ethical committee processes, and regulatory filings.
- Hands-on experience with EDC systems (Medidata Rave, REDCap, Oracle Clinical) and data management.
- Statistical literacy with proficiency in SAS or R; ability to interpret trial data and generate insights.
- Excellent written and verbal communication, project management, and cross-functional leadership.
- Ability to work in a fast-paced environment with multitasking and travel up to 20%.