The company is looking to develop innovative digital health products and solutions by leveraging wearables, smartphones, medical devices, AI, and health services.
Requirements
- Familiar with IRB study approval, GCP, FDA, and HIPAA requirements
- Experience with statistical software
- Experience with clinical trial documentation, SOPs, and safety monitoring
- Advanced degree (MD, PhD)
- Worked with clinical studies involving wearables
- Experience with Matlab
Responsibilities
- Designs and leads execution of product-critical physiological studies
- Provides Support to Clinical Research Organization (CRO) during planning and execution of clinical studies
- Performs clinical data analysis and provides statistical inferences as needed
- Operates, maintains and trains others on physiological data collection laboratory equipment
- Authors or oversees SOPs, safety monitoring, and regulatory
- Creates and maintains appropriate study and human subject documentation/records
- Reviews and negotiates clinical study budgets
Other
- Bachelor’s Degree, Master’s Preferred in related field or equivalent combination of education, training, and experience
- 3+ years of clinical data collection and analysis/clinical research experience in industry (e.g., medical device, SaMD, pharma)
- Project management and managing vendor relationships
- Develops and trains on junior associates on laboratory best practices and procedures for efficient, cohesive, and high-quality datasets
- Coach and mentor junior researchers, ECG technicians on planning and execution of studies & annotations
